h & p industries, inc. – FDA 483, May 18, 2010

During an FDA inspection from April 19 to May 18, 2010, H & P Industries, Inc. dba Triad Group, a manufacturer of drugs, medical devices, and cosmetics, received a Form FDA-483 citing significant violations of Good Manufacturing Practices and Quality System Regulations. For medical devices, key issues included inadequate validation of sterilization processes for lubricating jelly, with documented microbial growth in post-sterilization samples. The firm failed to establish proper finished device acceptance procedures, leading to the distribution of products that failed quality tests and a lack of investigation into initial failing results. Complaints regarding product quality, such as viscosity issues and adverse patient reactions, were not adequately investigated. Crucially, the company failed to submit required Medical Device Reports (MDRs) for serious adverse events and lacked written MDR procedures. Corrective and preventive actions related to high microbial bioburden were also poorly documented. For drug products, observations highlighted a lack of sterilization validation for alcohol swabsticks and non-adherence to validated parameters for alcohol pads. There was a systemic failure to follow written production and process control procedures, including disregarding Out-of-Specification (OOS) results by retesting until passing, without proper investigation. The company released drug products that did not meet specifications and did not use stability data to adjust expiration dates. Investigations into batch failures were not extended to other affected lots, potentially leading to the distribution of contaminated glycerin suppositories. Furthermore, critical procedures were either absent or not followed for activities like product repacking, material rechecking, and equipment cleaning and maintenance. Inadequate employee training was also noted. The regulatory framework underpinning these observations mandates adherence to strict quality and safety standards for medical devices and drugs. The company promised to correct several of the initial observations, indicating an expectation of comprehensive remedial actions to bring their operations into compliance.