FDA EIR - H & P Industries, Inc. - July 17, 2009

An FDA routine inspection of H & P Industries, Inc. dba Triad Group, an Over-the-Counter (OTC) drug manufacturer, was conducted from July 15-17, 2009. The inspection, guided by Compliance Program 7356.002, identified 21 significant Current Good Manufacturing Practice (cGMP) deficiencies, leading to the issuance of an FD 483. Key violations included the Quality Control unit's responsibilities not being adequately documented or followed, and insufficient frequency of cGMP training for employees. The company failed to extend investigations of out-of-specification drug batches to other similar products and performed reprocessing without proper Quality Control approval. Rejected in-process materials were not appropriately identified or controlled, and drug products failing established specifications were released, often after unjustified changes to those specifications. Furthermore, there was a lack of supplier qualification to ensure raw material reliability. Other issues encompassed unsanitary conditions in production areas, unapproved equipment qualification protocols, and the absence of process validation for OTC drug products. Management did not propose immediate corrective actions but committed to submitting a detailed written response to the FDA's Minneapolis District Office, outlining planned actions and timeframes.