FDA 483 - CFP Acquisitions Inc. - July 23, 2015

During an inspection from March 3 to March 13, 2015, the U.S. Food and Drug Administration (FDA) issued a Form 483 to The Apothecary Shoppe, LLC, identifying significant departures from Current Good Manufacturing Practice (cGMP) regulations for sterile drug production. The observations highlight critical issues across various aspects of the company's manufacturing processes. Key violations included inadequate personnel gowning, exposing drug products to contamination risk. The firm's environmental monitoring system for aseptic processing areas was deficient, lacking daily monitoring, proper documentation, and sufficient viable air and operator monitoring. Furthermore, the sterilization processes for drug products were not validated, and media fills did not accurately simulate production conditions. Cleaning and disinfection practices in aseptic areas were substandard, using non-sterile materials and unvalidated cleaning solutions. The facility's air supply system exhibited deficiencies, including incomplete HEPA filter testing and a documented lack of positive pressure differential in critical zones, compromising aseptic conditions. Other significant findings involved the absence of written procedures for equipment cleaning validation, a failure to routinely test sterile drug products for sterility and endotoxins, and the lack of a comprehensive stability testing program to justify Beyond Use Dates. Finally, the company did not conduct routine potency testing for all drug products before release and failed to calibrate critical electronic equipment, including temperature devices, pressure gauges, and balances. The Apothecary Shoppe, LLC is required to address these observations by implementing robust corrective and preventative actions to achieve compliance with cGMP standards.