Friday, May 31, 2019

Got a career dilemma?

I'm always game for writing answer requests for advice in my column at Chemical and Engineering News. Please feel free to write me (chemjobber@gmail.com) if you have a career-oriented dilemma that you'd like me to write about in the magazine. Also, you can submit your questions with this handy web form. Thanks!

Wednesday, May 29, 2019

Warning Letter of the Week: no confusion edition

1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). 
On October 24, 2018, our investigator observed torn documents of stability study data, analytical testing sheets, analysis calculations, and release forms that were placed into clear trash bags. Stability study documents for three batches of [redacted] mg tablets were salvaged from the trash and compared to the official and approved records. Out-of-specification (OOS) results were among the data found, however the official results were recorded as within specification. Additionally, it was observed that blank stability study forms were prepared, pre-signed, and approved by the quality unit before recording the test data. 
In your response, you acknowledged the multiple trash bags containing torn quality control documents and the practice of signing documents before recording the data. You stated the torn documents were from scale-up batches in which you tore the documents so as “not to create confusion in the mind of the investigator.” Your response was inadequate because you did not explain the discrepancies between the torn documents with OOS values and the documents retained by the quality control laboratory that included passing values. Additionally, you did not complete a retrospective evaluation of all potentially affected quality-related records to determine the scope of data integrity practices, including, but not limited to, the signing of blank documents before performing laboratory tests.
That. Is. Amazing. Unreal. 

This week's C&EN

Tuesday, May 28, 2019

The 2019 Chemistry Faculty Jobs List: 586 positions

The 2019 Chemistry Faculty Jobs List (curated by Andrew Spaeth and myself) has 586 positions. This post will be the final post of the 2018-2019 year.

Want to help out? Here's a Google Form to enter positions.

On May 29, 2018, the 2018 Chemistry Faculty Jobs List had 550 positions.

Interested in how this is tracking overall? Check out these sweet graphics done by Andrew Spaeth.

Otherwise, all discussions are on the Chemistry Faculty Jobs List webforum.

2018-19 Chemistry Bumper Cars is at Marshall Brennan's site.

The Academic Staff Jobs List: 31 positions

The Academic Staff Jobs list has 31 positions.

This list is curated by Sarah Cady. It targets:
  • Full-time STAFF positions in a Chem/Biochem/ChemE lab/facility at an academic institution/natl lab
  • Lab Coordinator positions for research groups or undergraduate labs 
  • and for an institution in Canada or the United States
Want to help out? Here's a Google Form to enter positions.

Want to chat about staff scientist positions? Try the open thread.

Monday, May 27, 2019

Memorial Day; back tomorrow

Tahoma National Cemetery (Kent, WA)
credit: Jackie Flores Jose
Today is Memorial Day in the United States; it's a national holiday.

Back tomorrow.

Friday, May 24, 2019

View From Your Hood: cloudy skies edition

Credit: Anonymous
Via a longtime reader, a view from their hood.

(got a View from Your Hood submission? Send it in (with a caption and preference for name/anonymity, please) at chemjobber@gmail.com; will run every other Friday.)

This week's C&EN

A few of the articles in this week's issue of Chemical and Engineering News

Got a career dilemma?

I'm always game for writing answer requests for advice in my column at Chemical and Engineering News. Please feel free to write me (chemjobber@gmail.com) if you have a career-oriented dilemma that you'd like me to write about in the magazine. Also, you can submit your questions with this handy web form. Thanks!

Thursday, May 23, 2019

The Medicinal Chemist Jobs List: 332 positions

The Medicinal Chemist Jobs list (curated by Joel Walker and myself) has 332 positions.

Want to help out? Here's a Google Form to enter positions, but if you want to do the traditional "leave a link in the comments", that works, too.

Want to chat about medchem positions? Try the open thread.

Positions I'm not including: positions outside the United States, computational positions (this will likely change), academic positions (likely never.)

43 new positions at Organic Chemistry Jobs

Over at Common Organic Chemistry, there are 18 new positions for May 22, 15 new positions for May 20 and 10 new positions for May 16.

The Analytical Chemistry Jobs List: 25 positions

The Analytical Chemistry Jobs List has 25 positions; this is curated by the ACS Division of Analytical Chemistry. Want to help out? Fill out this form. 

The Process Chemistry Jobs List: 300 positions

The Process Chemistry Jobs List has 300 positions.

Want to help? Here's a form to fill out.

Want to chat process jobs? Try the open thread. 

Wednesday, May 22, 2019

Chemjobber’s Conditions For Becoming Chemistry Jobs Czar

Spotted in a spam folder somewhere:

Chemjobber’s Conditions For Becoming Chemistry Jobs Czar
  1. Office in Midland, MI
  2. Walk-in privileges with the CEOs of Dow, DuPont, Pfizer, Merck and Novartis
  3. Full professor rank - at highest pay level for faculty
  4. Staff of 12 people (3 labor economists, 3 research analysts, 1 scheduler, 3 social media people, 1 beer assistant, 1 organizer of blue dress shirts) 
  5. CEOs of major chemistry employers sits down individually with Chemistry Jobs Czar and tells their HR people to follow the directive of the Chemistry Jobs Czar without delay, subject to doing anatomically impossible things in cases of disagreement
  6. 24/7 access to either a private jet or a lifetime supply of Glenfiddich
  7. Ability to spend weekends in Bozeman, Montana with family on way from chemistry career fairs
  8. Security detail if deemed necessary after security review.
  9. Serve as the face of chemistry employment policy - the principal spokesman on television and social media
  10. Promise by November 1, 2019, Congress will ratify CJ Chemjobber to be Secretary of Labor, unless Chemjobber wishes to continue in Czar position

Tuesday, May 21, 2019

The 2019 Chemistry Faculty Jobs List: 586 positions

The Academic Staff Jobs List: 31 positions

The Academic Staff Jobs list has 31 positions.

This list is curated by Sarah Cady. It targets:
  • Full-time STAFF positions in a Chem/Biochem/ChemE lab/facility at an academic institution/natl lab
  • Lab Coordinator positions for research groups or undergraduate labs 
  • and for an institution in Canada or the United States
Want to help out? Here's a Google Form to enter positions.

Want to chat about staff scientist positions? Try the open thread.

Monday, May 20, 2019

New York schools settle for over one million dollars for 2014 rainbow demonstration incident:

Well, this is a long time in coming. From the New York Daily News: 
Two students traumatized by a horrifically botched classroom science experiment in 2014 have received over $1 million from the city. Former Beacon High School student Julia Saltonstall received a $750,000 settlement. Her classmate Sara Salitan received $400,000, documents filed in Manhattan Supreme Court show. The deals were made official Monday, which was to be the first day of a trial over their injuries.
Saltonstall suffered burns on her forearms, including a third-degree burn on her right arm, when teacher Anna Poole screwed up the chemistry “rainbow experiment.” She’d since coped with emotional trauma. Salitan’s injuries were “purely emotional and psychological in nature, including post traumatic stress disorder and depression,” according to a recent filing in the case. Messages for Saltonstall and Salitan’s attorneys were not returned....
...The rainbow experiment was designed to show students how different mineral salts produce multicolored flames when burned. On Jan. 2, 2014 Poole poured methanol from a one-gallon bottle into hot Petri dishes containing nitrates that had been on fire only moments earlier. The chemical cocktail created a blazing ribbon that flew across the table where Poole’s students were gathered, engulfing Yanes.... 
...The Daily News exclusively reported last year that Poole had received a promotion and was now working in the Education Department’s central office providing instructions to other educators about science-teaching techniques. 
Poole could not be reached for comment.
Well, maybe after another 25 kids are hurt and another couple million dollars in settlements are paid out that we'll get some change.

Another reminder that the American Chemical Society's Committee on Chemical Safety specifically recommends teachers "that the “Rainbow” demonstration on open benches involving the use of flammable solvents such as methanol be discontinued immediately due to extreme risk of flash fires and flame jetting."

Friday, May 17, 2019

Got a career dilemma?

I'm always game for writing answer requests for advice in my column at Chemical and Engineering News. Please feel free to write me (chemjobber@gmail.com) if you have a career-oriented dilemma that you'd like me to write about in the magazine. Also, you can submit your questions with this handy web form. Thanks!

GC columns

A list of small, useful things (links): 
An open invitation to all interested in writing a blog, a hobby that will bring millions thousands hundreds tens of dollars joy and happiness. Send me a link to your post, and I'd be happy to put it up.

Have a good weekend!

Job posting: Scientist Urethane Catalysts, Huntsman Advanced Technology Center, The Woodlands, TX

From the inbox:
We are currently looking for a dynamic individual as a Scientist, Urethane Catalysts for our Performance Products organization at our Advanced Technology Center located in The Woodlands, Texas. 
This job exists to support our urethane catalyst business of our Performance Products Division.  Incumbents help develop and deploy new or modified products as well as troubleshooting issues that customers may have with existing products.  Assists the business to achieve these goals through laboratory experimentation, product/application development, customer trials, customer technical service support, and other activities....
What will be expected from you?
  • Conduct laboratory investigations in order to develop new products, application technologies and/or to provide technical service support which demonstrates the ability to effectively resolve a variety of moderately complex technical service or product development/modification challenges
  • All work must include well written concise reports which are completed on time and exhibit rigorous data analysis skills....
What are we looking for in the ideal candidate?
  • Bachelor’s Degree in Chemistry, Chemical Engineering, or Material Science is required.
  • 3+ years of relevant experience in a laboratory environment or
  • Demonstrated knowledge in isocyanates, polyols and related chemistry as well as a strong working knowledge of ridge and flexible polyurethane foam systems
  • Proven experience of formulating ridge and flexible polyurethanes foams...
Full ad here. Best wishes to those interested.  

Thursday, May 16, 2019

The Medicinal Chemist Jobs List: 332 positions

The Medicinal Chemist Jobs list (curated by Joel Walker and myself) has 332 positions.

Want to help out? Here's a Google Form to enter positions, but if you want to do the traditional "leave a link in the comments", that works, too.

Want to chat about medchem positions? Try the open thread.

Positions I'm not including: positions outside the United States, computational positions (this will likely change), academic positions (likely never.)

26 new positions at Organic Chemistry Jobs

Over at Common Organic Chemistry, there are 26 new positions for May 12.

The Analytical Chemistry Jobs List: 25 positions

The Analytical Chemistry Jobs List has 25 positions; this is curated by the ACS Division of Analytical Chemistry. Want to help out? Fill out this form. 

The Process Chemistry Jobs List: 300 positions

The Process Chemistry Jobs List has 300 positions.

Want to help? Here's a form to fill out.

Want to chat process jobs? Try the open thread. 

Wednesday, May 15, 2019

"The Difference A Lab Coat Can Make"

Via a report in the Salt Lake Tribune (by Courtney Tanner) and help from Twitter, this rather alarming report from the Utah State Legislature about an incident at the University of Utah:
A University of Utah Incident Demonstrates The Difference a Lab Coat Can Make 
In February 2018, an incident in the University of Utah’s Chemistry Department led to chemical burns for two lab personnel. This incident involved air-reactive chemicals that combust when exposed to air, which was the hazard that led to the 2008 death of a UCLA researcher. In this incident, the researcher conducting the experiment and their spotter, who had a fire extinguisher, each received burns. Figure 1.2 shows the lab coat and burns resulting from the accident.  
In this case, the researcher was wearing a flame-resistant lab coat or more serious injury could have occurred. Unfortunately, we observed and OEHS has reported repeatedly that lab coats in general are not being worn consistently.  
Unlike the incident at UCLA, two major differences were observed in the University of Utah’s incident report. First, the researcher was wearing the flame-resistant blue lab coat shown in Figure 1.2. As the figure shows, the air-reactive chemical left burn marks in the material. However, an incident report noted that the clothing and skin beneath the coat were unaffected. The second major difference was that a spotter was present to extinguish the chemical. Neither of these safety precautions were present in the UCLA tragedy. 
After the Chemistry Department’s Safety Committee reviewed the incident, the following improvements to this specific lab group’s safety practices were identified.
  • Use Fire-Resistant Gloves: While the researcher’s nitrile gloves did not melt, second-degree burns were still incurred. Another research group in the Chemistry Department uses fire-resistant pilot gloves, which were recommended for future use when air-reactive chemicals are involved.
  • Build Larger Margins of Safety into Procedures: The fire resulted when the plunger of the 5 mL syringe came out while drawing 4.6 mL of the chemical. A proposal to fill syringes only to 60 percent of capacity when working with air-reactive chemicals was developed, a level significantly lower than 92 percent of syringe capacity that caused this incident. 
This is a good and regrettable reminder that it's hard to learn from our history, even incidents that were famous just ten years ago. I find it a little bit depressing that this incident happened, and that so much of it was predictable from the Sheri Sangji incident, i.e. the lesson from the incident that a syringe must be properly sized for the amount that it needs to withdraw was not followed in this case. 

However, there is cause for hope. If this had happened 10 years ago or 20 years ago, the student would not have been wearing a flame-resistant lab coat, and the researcher would have sustained far more life-threatening injuries. In addition, I suspect that the presence of a spotter with a fire extinguisher at the ready was also a procedure added post-Sangji. Little by little, I sincerely hope that academic chemistry's safety record is improving. 

(Questions that I don't have time right now: What the ##$$ is it going to take for us to get reports of serious incidents or near misses out of industry or academia on a regular basis? There should be some kind of central repository of these incidents that can be anonymized so that the community can learn.)

UPDATE 0515191700: Jyllian Kemsley reminds us about the Pistoia Alliance Chemical Safety Library.

Tuesday, May 14, 2019

The 2019 Chemistry Faculty Jobs List: 585 positions

Job posting: Core Facility Research Specialist, University of Iowa, Iowa City, IA

From the inbox, a position with a core facility at the University of Iowa:
The University of Iowa Materials Analysis, Testing, and Fabrication (MATFab) Facility is an Office of the Vice President for Research core resource, offering a wide array of instrumentation to research investigators.   
Position: The MATFab Facility is seeking a Core Facility Research Specialist to: support medium- to ultra-high vacuum, electron emission and detection, deposition, and etching instrumentation for materials fabrication and characterization including e-beam lithography, scanning electron microscopy (SEM), reactive-ion etching, atomic-layer deposition, photolithography, and chemical vapor deposition.
Position ad here and here. Best wishes to those interested. 

The Academic Staff Jobs List: 31 positions

The Academic Staff Jobs list has 31 positions.

This list is curated by Sarah Cady. It targets:
  • Full-time STAFF positions in a Chem/Biochem/ChemE lab/facility at an academic institution/natl lab
  • Lab Coordinator positions for research groups or undergraduate labs 
  • and for an institution in Canada or the United States
Want to help out? Here's a Google Form to enter positions.

Want to chat about staff scientist positions? Try the open thread.

Monday, May 13, 2019

You'll never look at a pill bottle the same way again

The New York Times has an interesting snippet from an upcoming book about the generic drug industry by Katherine Eban: 
A new head of the F.D.A.’s India office, Altaf Lal, arrived in mid-2013. To tame the twin problems of company fraud and compromised investigators, Mr. Lal made a novel pitch to agency officials. He proposed a pilot program to make all inspections in India either on short notice or unannounced. By December 2013, he had a green light. The results were instantaneous. 
In January 2014, the F.D.A. was planning an unannounced inspection at a plant in northern India on a Monday. Fearing that plant officials had heard they were coming, Mr. Baker and his colleague went a day early, unannounced. They proceeded to the quality control laboratory, expecting it to be quiet on Sunday morning. Instead, they were stunned to see a hive of activity. Dozens of workers hunched over documents, backdating them. On one desk, Mr. Baker found a notebook listing the documents the workers needed to fabricate in anticipation of the inspectors’ arrival. There were Post-it notes stuck to some surfaces, noting what data to change. 
In large swaths of India’s generic drug industry, the pilot program uncovered a long-running machinery dedicated not to producing perfect drugs but to producing perfect data. At one plant, Mr. Baker went straight to the microbiology laboratory and found the paperwork for testing the sterility of the plant in perfect order: microbial limits testing, biological indicators, all the samples with perfect results. Yet most of the samples didn’t exist. The plant was testing almost nothing. The laboratory was a fake.
It's a good thing that pilot program is continuing. What's that you say? The FDA canceled it? Oh, well. 

Job posting: Division Director, Division of Chemistry, National Science Foundation, Alexandria, VA

From the inbox, a position at the National Science Foundation:
The Directorate for Mathematical and Physical Sciences (MPS) announces a nationwide search to fill the position of Division Director, Division of Chemistry (CHE). Appointment to this Senior Executive Service position may be on a career basis, or on a one- to three-year limited-term basis, with a salary range of $165,842 to $175,400. Alternatively, the incumbent may be assigned under the Intergovernmental Personnel Act (IPA) provisions. Information about the Division’s activities may be found at https://www.nsf.gov/div/index.jsp?div=CHE
The successful candidate will possess an established record of significant achievement in research administration as well as leadership responsibility in academe, industry or government. In addition to having a strong record of research and education accomplishments within his or her technical communities, the Division Director must be experienced and competent in technical, financial, and administrative management. He/she must work well with people, be an effective communicator, and act as a mentor to continuously develop the diversity of talents and skills of his or her colleagues at all levels. 
Full ad here. Best wishes to those interested. 

Friday, May 10, 2019

View From Your Hood: new chemistry building edition

Credit: Tariq Bhatti
From reader Tariq Bhatti, of Rutgers - New Brunswick:

"I like this view, looking west toward the hills and the bend in the Raritan River. The glass facade offers sweeping views of sunsets (and sunrises).  On clear nights, we can see Manhattan in the distance. The cogeneration plant is also visible. We were nonplussed by the giant caffeine molecule that was installed one morning ("The PhD Molecule"), but we're learning to embrace it."

(got a View from Your Hood submission? Send it in (with a caption and preference for name/anonymity, please) at chemjobber@gmail.com; will run every other Friday.)

Demographics is destiny, workforce edition

Another article about the so-called 'skills gap':
“Work force is the number one challenge for manufacturers,” she told KRMG recently. “The average age of a high-skilled worker is 56, and so we don’t have enough people interested and familiar with skilled trades to fill those positions.”
It's amazing to me that employers act like they haven't known for years that some significant cohort of their employees were going to retire, and that they would have to work harder to fill those positions. If that person is 56, I dunno, you've had at least 10 years to make a move? Maybe 20? Amazing. 

Got a career dilemma?

I'm always game for writing answer requests for advice in my column at Chemical and Engineering News. Please feel free to write me (chemjobber@gmail.com) if you have a career-oriented dilemma that you'd like me to write about in the magazine. Also, you can submit your questions with this handy web form. Thanks!

Thursday, May 9, 2019

The Medicinal Chemist Jobs List: 332 positions

The Medicinal Chemist Jobs list (curated by Joel Walker and myself) has 332 positions.

Want to help out? Here's a Google Form to enter positions, but if you want to do the traditional "leave a link in the comments", that works, too.

Want to chat about medchem positions? Try the open thread.

Positions I'm not including: positions outside the United States, computational positions (this will likely change), academic positions (likely never.)

14 new positions at Organic Chemistry Jobs

Over at Common Organic Chemistry, there are 14 new positions for May 7.

The Analytical Chemistry Jobs List: 24 positions

The Analytical Chemistry Jobs List has 24 positions; this is curated by the ACS Division of Analytical Chemistry. Want to help out? Fill out this form. 

Wednesday, May 8, 2019

Laboratory Life: A Poem, by @ChemistryCayk

By @ChemistryCayk

why do so many experiments fail?
why does glassware take so long to come in the mail?
why is this protein absurdly expensive?
why is this metal salt moisture- and air-sensitive?

optimise the methods and hope for the best
so, that one didn't work, which experiment is next?
adjust one parameter... well, that didn't work
let's see what the fit shows on Lineweaver-Burk

react for an hour, and then over night
huh, that's kind of funny, yes, that doesn't seem right
collect all the data, and well, it looks strange
these points seem just fine, but some are out of range

try this again, remember to take the flask
a seemingly simple but often forgotten task
label the falcon tubes and all of the vials
if the samples get mixed up, I will be sad for a while

back to the drawing board, what have I learned
from past experiments that have crashed and burned
this process is tough, and though I am stressed
I have to remember I am doing my best

This week's C&EN

A few of the articles in this week's issue of Chemical and Engineering News:

Tuesday, May 7, 2019

Event: ChemDraw Day, Yale University, Thursday, May 9

  • Do you switch to ACS 1996 style settings every time you launch ChemDraw?
  • Do you make copies of molecules using Ctrl+C / Ctrl+V ?
  • Do you manually adjust the components of your reactions after drawing?
  • Does it take you more than 5 min to draw a single catalytic cycle?
If you answered “Yes” to one or more, you may not be as efficient as you think you are! Let the Experts show you what you didn’t know you could accomplish. Whether you have been using ChemDraw for 5, 10, 20 years or since Version 1 back in 1985, we know that you will learn something that will improve your productivity 5-10 fold. This event is OPEN to universities and companies in the CT area. Lunch and drinks will be provided with an opportunity to network!
When: Thu, May 9, 2019, 11:30 AM – 1:30 PM EDT
Where: Sterling Chemistry Laboratory Room 110, 225 Prospect Street, New Haven, CT 06511
Cost: free 
Register here. Coming as a group? Please register individually.  

The 2019 Chemistry Faculty Jobs List: 584 positions

The Academic Staff Jobs List: 31 positions

The Academic Staff Jobs list has 31 positions.

This list is curated by Sarah Cady. It targets:
  • Full-time STAFF positions in a Chem/Biochem/ChemE lab/facility at an academic institution/natl lab
  • Lab Coordinator positions for research groups or undergraduate labs 
  • and for an institution in Canada or the United States
Want to help out? Here's a Google Form to enter positions.

Want to chat about staff scientist positions? Try the open thread.

Sunday, May 5, 2019

Silicone plant in Illinois explodes, four believed dead

Four people were transported to area hospitals after an explosion at the AB Speciality Silicone plant in Waukegan late Friday night. Steve Lenzi, spokesman for the Waukegan Fire Department, said officials were working with a plant manager to determine how many people were working in the Sunset Avenue factory when the explosion happened. 
Speaking around midnight, Lenzi added officials did not know what caused the explosion. "We have fire and structural damage indicative of an explosion," Lenzi said at the scene. "There is very heavy damage.” 
Two people were taken to Vista Medical Center East in Waukegan and two were taken to Advocate Condell Medical Center in Libertyville, Lenzi added.... 
...According to the company website, AB Speciality Silicone is a manufacturing and distribution company specializing in silicone products. 
Nancy Carreno, who lives on Atlantic Avenue near the plant, said the explosion didn’t break any windows but it was loud. “The explosion was a big boom and the ground shook. Our cable TV flickered and the electricity, and then it came back on,” she said.
Here's video of the explosion (wait for it.) Four dead - here's hoping that's the extent of the death toll. It will be interesting to hear what CSB thinks of this.  

Friday, May 3, 2019

TLC plate cutters

A list of small, useful things (links):
An open invitation to all interested in writing a blog, a hobby that will bring millions thousands hundreds tens of dollars joy and happiness. Send me a link to your post, and I'd be happy to put it up.

Have a good weekend!

Got a career dilemma?

I'm always game for writing answer requests for advice in my column at Chemical and Engineering News. Please feel free to write me (chemjobber@gmail.com) if you have a career-oriented dilemma that you'd like me to write about in the magazine. Also, you can submit your questions with this handy web form. Thanks!

Thursday, May 2, 2019

Job posting: 2 remote positions, Master Organic Chemistry

Friend of the blog James Ashenhurst is looking for two part-time employees for his website:
Master Organic Chemistry (MOC) is hiring for two part-time (10+ hours/week), non-lab, 100% remote positions: Organic Chemistry Literature Researcher, and Chemical Drawing Assistant.
Best wishes to those interested. 

31 new positions at Organic Chemistry Jobs

Over at Common Organic Chemistry, there are 14 new positions for May 1, 10 for April 28 and 7 for April 25.

The Analytical Chemistry Jobs List: 23 positions

The Analytical Chemistry Jobs List has 23 positions; this is curated by the ACS Division of Analytical Chemistry. Want to help out? Fill out this form. 

Wednesday, May 1, 2019

Warning Letter of the Week: homeopathic validation edition

A love note from the Office of Pharmaceutical Quality Operations, Division II to the CEO of Newton Laboratories: 
2. Your firm failed to establish written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). 
You failed to validate your drug manufacturing processes. Unvalidated production processes increase the probability that your products will vary in identity, strength, quality, and purity. Your failure to validate your drug manufacturing processes means that you cannot assure consistency in the quality of your finished products and may result in variable levels of potentially toxic ingredients in them. 
Your homeopathic drug products are indicated for treating conditions in infants and children, and they are manufactured from ingredients such as Nux vomica, Belladonna, Aconitum napellus, and Gelsemium sempervirents that pose potentially toxic effects. For example, Nux vomica contains strychnine. Strychnine is a highly toxic, well-studied poison that is used as a rodenticide. 
You released numerous lots of homeopathic drugs without validating your manufacturing processes. Before any batch is commercially distributed for use by consumers, a manufacturer should have gained a high degree of assurance in the performance of the manufacturing process such that it will consistently produce drug products meeting attributes relating to identity, strength, quality, and purity. Information and data should determine if the commercial manufacturing process is capable of consistently producing acceptable quality products under commercial manufacturing conditions. Failure to validate manufacturing processes could expose patients to unnecessary risks due to the lack of knowledge about and control over sources of variation. 
This is a repeat and persistent observation that was also cited during inspections conducted in 2012 and 2017.
How the heck do you validate the manufacture of homeopathic products?!?!?!?

This week's C&EN

A few articles from this week's issue of Chemical and Engineering News: