Wednesday, January 2, 2019

Warning Letter of the Week: can't come in edition

...Your firm limited the inspection and/or refused to permit the FDA inspection as follows: 
1. Barring access to areas 
During the inspection, your firm limited the investigator’s access to the manufacturing area. Your employee stated that your firm was currently manufacturing and packaging drug products; however, you prevented the investigator from entering the manufacturing area. 
2. Refusal to provide copies of documents 
During the inspection, FDA requested records, including a list of drug products you manufacture, as well as some of your facility’s shipping records. Your firm limited the inspection by refusing to provide copies of these records to FDA. 
Access to Information During Inspection 
When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act....
Welp, that's one way to avoid getting a long detailed list of findings.


  1. CJ: Did you read Bad Blood, about the Theranos scandal? If not, you should. It's 300+ pages of this kind of crap.

    1. Sure did, it was pretty crazypants.

    2. Theranos actually told the FDA they couldn't come in and inspect? I figured the situation at Skylark had to be a case of some low-level employee denying entry to a stranger, and no one would be crazy enough to intentionally tell the FDA they can't do an inspection!


looks like Blogger doesn't work with anonymous comments from Chrome browsers at the moment - works in Microsoft Edge, or from Chrome with a Blogger account - sorry! CJ 3/21/20