H & P Industries, Inc. – FDA 483, Jul 17, 2009

An FDA inspection of the Triad Group facilities, conducted from July 15-17, 2009, identified significant deviations from Current Good Manufacturing Practice (cGMP) regulations, as detailed in a Form FDA 483. The inspection revealed numerous issues across key operational areas. Main violations included critical deficiencies in the Quality System, such as unwritten quality control responsibilities, infrequent cGMP training, and a failure to adequately investigate Out-of-Specification (OOS) results or extend investigations to other affected batches. The company was also cited for reprocessing without quality unit approval, improperly managing rejected materials, and releasing drug products that did not meet specifications. Regarding Facilities and Equipment, observations noted inappropriate equipment design (e.g., plastic transfer buckets, chipped scrapers) and inadequate maintenance, leading to potential contamination risks. Cleaning and maintenance procedures were often not followed or lacked sufficient detail, and critical equipment lacked proper qualification records. Furthermore, Laboratory Controls were found lacking, with unvalidated test methods (e.g., HPLC), improperly qualified analytical instruments in use, and an absence of statistically sound sampling plans for incoming materials. Production and Process Controls issues included unvalidated manufacturing processes for OTC drug products, inadequate controls to prevent microbiological contamination, and poor control over labeling materials. In response, Triad Group outlined a comprehensive plan to address each observation. Their required actions involved revising and implementing numerous procedures for quality unit responsibilities, training, OOS investigations, cleaning, maintenance, and material handling. They committed to purchasing improved equipment, enhancing employee training, establishing proper quarantine areas, and initiating extensive validation programs for test methods, equipment, and manufacturing processes, with committed completion dates and regular progress updates. The company affirmed its dedication to achieving full regulatory compliance.