Come On Man…
|if you watch ESPN Sports Center you have probably heard the announcers do their Come on Man bit. Well perhaps we should have something similar for the pharmaceutical industry when they do something just plain dumb….
How about a CMO in North Carolina that recently received a FDA warning letter. This is one of those what were ya thinkin moments (From Observation 1):
Your firm manufactured topical human drugs and several pesticides in the same building, using shared equipment. It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture pesticides or other non-pharmaceutical products due to the risk of cross-contamination.
Records we reviewed during our inspection and information you submitted in your response confirmed that two of the human drugs you manufactured contained the pesticide [redacted]. You manufactured the pesticide and the human drugs using shared equipment.