FDA 483 - Inopak Ltd - August 03, 2023

An FDA inspection of Inopak Ltd in Ringwood, NJ, a drug manufacturer, revealed significant deficiencies in its quality control unit's responsibilities and procedures. The firm failed to adequately evaluate formulations, review laboratory results, conduct stability studies, and review executed batch records for its OTC drug products. Additionally, Inopak Ltd lacked proper oversight for approving or rejecting contract-manufactured drug products and failed to perform critical testing like benzene content, impurities, and microbiological testing on several distributed products.