FDA Tells Contract Manufacturer to Hire a GMP Consultant

Contract Pharmacal of Hauppauge, N.Y., received an FDA warning letter for manufacturing processes that violated current GMP regulations and for manufacturing several products without approved applications.

Additionally, Contract Pharmacal told the FDA that it would be discontinuing the manufacture of several unapproved drugs, but it did not say that all unapproved drugs would be discontinued.

Other citations include a lack of standard operating procedures for sampling plans for out-of-specification results and issues with user access to computer systems with raw data, inventory control and coating solution expiration dating.
Drug GMP Report