FDA Warning Letter to OTC Manufacturer


In a recently posted FDA warning letter to OTC Manufacturer, the OTC manufacturer in Canada received 6 observations.

This is one of the few warning letters where FDA calls out executive management for failure to provide oversight and control of drug manufacturing.
The OTC firm had promised actions from prior inspections – but failed to implement most if not all of the correction/ corrective actions.
The firm got hit with some of the big items:
211.63 failure for equipment design, size and maintenance
211.100(a) – failure to have written procedures – no validation program!
211.67(a) – no cleaning validation program/ data
211.166(a) – No stability program/ data to justify expiration dates
211.84(d) 1 and 2 – no testing of incoming raw materials, no vendor qualification program,
211.22 (a) & (d) – no effective Quality unit, responsibilities of QU not defined.
This warning letter is a great example on what not to do if you are a GMP manufacturer!
End result – according to the warning letter the firm ceased OTC drug manufacturing at the troubled site (Brampton) and moved all GMP manufacturing to second site (Mississauga) which had been assessed by FDA as being in compliance.  However, the FDA does plan to verify implementation of corrective actions and production change controls on their next inspection of the Mississauga site… so we will see what happens.