FDA 483 - Wells Pharmacy, Inc - October 20, 2016

An FDA inspection of Wells Pharmacy Network, LLC, a sterile product producer in Dyersburg, TN, occurred from September 12 to October 20, 2016. The inspection concluded with a Form FDA 483, highlighting several significant deviations from Good Manufacturing Practices. Major findings included inadequate facility maintenance, such as gaps in the ISO 5 cleanroom and water damage in adjacent areas, posing contamination risks. The firm used non-depyrogenated blister packaging for drug products, failing to ensure suitability for sterile use. Further observations noted critical contamination prevention issues, including insufficient cleaning of non-dedicated equipment, a cracked balance in the bulk drug mixing area, and equipment not meeting manufacturer specifications. Environmental control deficiencies were also cited, specifically inadequate use of sporicidal agents in cleanrooms and failures in microbiological contamination prevention procedures. This encompassed insufficient media fills for personnel qualification, lack of investigation into environmental monitoring excursions, and inaccurate documentation. Finally, the firm did not conduct smoke studies under dynamic conditions to qualify critical cleanroom areas. Wells Pharmacy Network, LLC must implement comprehensive corrective actions to address these observations, ensuring compliance with regulatory standards and safeguarding product quality and patient safety.