FDA 483 - PRIMROSE CANDY CO - December 01, 2010

An FDA inspection of Primrose Candy Co in Chicago revealed numerous significant deficiencies in their manufacturing and quality control processes for OTC drug products, primarily cough drops. The firm repeatedly failed to reject out-of-specification products, lacked proper quality control unit authority and written procedures, and exhibited widespread issues with laboratory controls, record-keeping, and process validation. Many of these observations were repeats from a previous inspection, indicating a persistent lack of compliance with cGMP regulations.