Quality systems? We don’t need no stinking quality systems.

FDA warning letters are always interesting reading. Typically, these warning letters describe quality systems which, despite good intentions, have gone awry. However, sometimes the warning letters are simply shocking.  This is the case with this letter recently sent to Wockhardt. 

It’s hard to know where to begin with this one, but let’s start here:

For example, on March 18, 2013, the FDA investigators found unofficial batch records for approximately 75 batches of injectable finished drug products torn in half in a waste area. These records contain data indicating that some batches failed to meet the in-process visual inspection specifications of not more than (b)(4)% defects, while the official batch records for these batches state that these batches had met the specifications. The uncontrolled documents indicate that up to 14% of vials had defects including, but not limited to, black particles, fibers, glass particles, sealing defects, and volume variations. According to your firm’s procedures, a defect rate higher than (b)(4)% requires initiation of an investigation; however, a senior production officer at your firm stated that no investigations are performed when this occurs. 

This is jaw dropping, if not criminal.  There were two sets of books, one for the GM to review and discard, and second set of records for auditors.  Only the government could be so understated in their response to this; The above examples raise serious concerns regarding the integrity, reliability and accuracy of the data generated and available at your facility.

The warning letter goes on and on, but comes to a crescendo with this:

For example, our investigators found that the washing and toilet facility located approximately twenty (20) feet (approximately 6 meters) from the entrance/gowning area to the Sterile Formulation (b)(4) manufacturing facility was found to have urinals that lacked drainage piping.  The urine was found to fall directly onto the floor, where it was collected in an open drain.  Stagnant urine was observed near the open drain.  In addition, the investigators also observed what appeared to be mildew or other mold(s) in this toilet facility. The facilities used in the manufacture of drugs should be appropriately maintained and repaired, and remain in a clean condition.

I would like to emphasize that I have never witnessed anything even remotely like this in working with ASI’s clients, nor in any of my previous positions within the industry. My own experience has been quite the contrary; talented, hardworking people doing their best to ship quality products to the consumer. The Wockhardt warning letter is a true anomaly, and I sincerely hope that the FDA deals with this case appropriately.