FDA 483 - PRIMROSE CANDY CO - September 26, 2017

An FDA inspection of Primrose Candy Co, an OTC drug manufacturer in Chicago, revealed significant deficiencies in its quality control and manufacturing processes for menthol lozenges. The firm failed to establish adequate laboratory controls, including proper assay procedures, equipment calibration, and stability testing. Additionally, the company released drug products without proper testing and lacked process validation, indicating a systemic failure to ensure drug product quality.