Wednesday, July 1, 2015

Warning Letter of the Week: beta-lactam cross-contamination edition

It's not something I think about a lot, but apparently the FDA cares a lot about beta-lactam allergies (and good for them!). From a recent warning letter to a Ontario repackaging facility: 
...These practices create an unacceptable risk of beta-lactam cross-contamination in other beta-lactams and in non-beta-lactam APIs.

During the inspection, you stated that you ceased penicillin operations.  However, you manufacture other beta-lactam products beyond penicillin, so ceasing penicillin operations is inadequate to address non-penicillin beta-lactams. You should take similar efforts to mitigate the risks of cross-contamination by non-penicillin beta-lactams, because they pose similar risks to patients.... 
,,,Cleaning cannot substitute for proper segregation.  Cross-contamination with your sensitizing agents can initiate life-threatening allergic reactions or other drug-induced hypersensitivity reactions.  Your current practices demonstrate an unacceptably high risk of beta-lactam cross-contamination into other APIs packaged at your facility.  You should conduct all beta-lactam manufacturing activities in dedicated, segregated facilities with separate air handling systems and production equipment.

No safe level of penicillin contamination has been determined to be a tolerable risk. Severe allergenic response can occur in susceptible patients exposed to extremely low levels of penicillin and other beta-lactams. Such levels are difficult to detect with current analytical methods.
"No safe level" is pretty strong language, even for a FDA warning letter.  


  1. Any thoughts on this one.. especially since it concerns the issue of unionization in STEM jobs.

    Scientist Union's Talks Stall Over Pay (

    "The Sacramento Bee reports that the labor contract between California's state government and the 2,800 employees represented by the California Association of Professional Scientists expired this week, spotlighting yet again the long-running feud over whether the tiny union's members should earn as much as their peers in federal and local governments and private industry. "It's a challenge to keep people motivated," says Rita Hypnarowski. "We talk about retaining the best and the brightest, but I can see that's not going to happen." A recent survey by the Brown administration found that the total compensation for half of state-employed chemists is less than $8,985 per month ($5,715 in salary, plus $3,270 in benefit costs). That's 33 percent less than the median total compensation for federal chemists, nearly 13 percent less than the midpoint for local-government chemists and almost 6 percent below the private sector."

    1. It is off-topic.

      That said, I can't resist trying to point out that CA is beyond broke, and CA's peculiar brand of political idiocy is going to cost the US a lot - so the CAPS is out of luck. I do not put it past our Fearless Leaders in the District of Corruption to engage in some resource and capital reapportionment to prop up this failed state so instrumental to their own banana republic-esque retention of power. But the CAPS is out of luck - there are far too many far more expensive shortfalls in the CA economy.

      Now let's get back to β-lactam cross-contamination.


      You mean the CA with the record budget surplus? Amazing things happen when voters force Republicans out of the way.

    3. Unfortunately this is the same CA with record public pension fund woes:

      CalSTRS alone is $71 BILLION IN THE HOLE - that's $1 BILLION more than Puerto Rico.

      It's also the same CA with pending municipal bankruptcies:

      Vallejo, San Bernadino, Stockton, Mammoth Lakes... maybe San Jose to follow.

      ...and it's the same state with total debt of $778 BILLION - making it the US leader in unfunded liabilities by state.

      Yes, it's amazing what happens when voters opt for financial ruin. But hey, they're voters.

    4. Anon3:15p: Just wanted you to know that I saw your comment and I had already written most of my piece before you wrote in, but thanks for the ping.

    5. ...and now Brown wants to raise taxes to fund transportation infrastructure that was neglected in the budget, now that the budget spending has been allocated. The new transportation spending includes some fraction of the estimated $70 billion cost for high-speed rail, and some fraction of the estimated $60 billion needed for maintenance and repairs. None of this was included or even discussed in CA's "record budget surplus," nor was addressing CA's $778 billion debt. On reflection, "CA budget surplus" must be about as meaningless an oxymoron as one can find.

  2. Thank god the FDA just vindicated everything I said!