4. Failure to properly keep buildings and facilities used in the manufacture of API in a clean condition.Leapin' lizards!
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.
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: