Wednesday, August 31, 2016

Warning Letter of the Week: lizard edition

In a friendly missive from the FDA to the general manager of Unimark Remedies Ltd., this comment about a API manufacturing area:
4.   Failure to properly keep buildings and facilities used in the manufacture of API in a clean condition.
Among other observations, our investigator found that the walls of your manufacturing area had open holes that could permit ingress of insects, birds, lizards, rodents, or other animals to the manufacturing space. During the inspection, the investigator observed dirt and birds in the manufacturing area as well as a lizard in the controlled [redacted] processing area. Your response states that this area of your facility was [redacted]and that the [redacted] had [redacted]. Nonetheless, our investigators found a batch record inside this area demonstrating that you had been conducting manufacturing operations in this space as recently as August 2, 2015 — one day prior to the beginning of the inspection.
Leapin' lizards!


  1. That lizard was the assistant manager!

  2. It was a lizard which was tripping on the API and thought it was a manager. (We all know that only snakes become managers! :-)

  3. Worse, the lizard had no visible security badge, and when asked, failed to provide identity credentials showing permission to work in the facility.

  4. I work at a CRO in the midwest. We constantly have dead frogs in our halls and sometimes labs. The next day they are usually gone but a day or three later, a few more dead frogs appear. This happens every late spring/summer through fall.

  5. Perhaps the lizard was a GEICO insurance agent.