William R. Grace M.D. P.C. – FDA 483, Jul 8, 2016

An FDA inspection conducted at William R. Grace M.D. P.C. on June 28, 29, and July 8, 2016, identified significant deficiencies in the production of sterile drug products. The observations, detailed in a Form FDA 483, highlight several areas requiring immediate corrective action to ensure product quality and patient safety.Key issues included inadequate cleaning and maintenance of equipment. Specifically, non-sterile wipes and disinfectants of unknown concentration were used for critical sterile environments, and a biological safety cabinet exhibited visible soilage and lacked current certification data. Operators demonstrated inadequate aseptic techniques, including the use of non-sterile gloves and a complete lack of training or qualification for preparing sterile drug products.Furthermore, the facility design presented contamination risks, with critical sterile processing areas lacking adequate air quality controls and being located too close to potential sources of contamination like sinks and refrigerators. Finally, the firm failed to adequately test drug products purporting to be sterile. This included the absence of stability-derived expiration dates and sterility testing for IV flush bags after multiple withdrawals. Expired sterile injectable medications were also found stored on-site. These observations indicate non-compliance with current Good Manufacturing Practices (cGMP) and necessitate a comprehensive response and corrective actions from William R. Grace M.D. P.C.