FDA 483 - Inopak Ltd - August 03, 2023

An FDA inspection of Inopak Ltd, a drug manufacturer in Ringwood, NJ, revealed significant deficiencies in its quality control unit regarding contract-manufactured OTC drug products. The firm failed to establish and follow written procedures for quality control, including evaluating formulations, reviewing laboratory results, and managing batch records. Additionally, Inopak Ltd did not perform essential testing, such as for benzene content and microbiological contamination, on finished products distributed to the U.S. market.