FDA 483 - Ferndale Laboratories, Inc. - March 04, 2022

Ferndale Laboratories, Inc., a manufacturer in Ferndale, MI, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in the quality control unit's authority to conduct full investigations, a failure to thoroughly review unexplained discrepancies and out-of-specification results for drug products and excipients, and a lack of written procedures to prevent objectionable microorganisms in non-sterile drug products. These issues indicate a need for improved quality system oversight and investigation practices.