FDA 483 - Downing Labs, LLC - November 19, 2018

Downing Labs, LLC, a producer of sterile drugs, underwent an FDA inspection between September 17 and November 19, 2018. The inspection identified several significant issues indicating non-adherence to regulatory expectations for sterile drug manufacturing. Key observations included failures in maintaining aseptic conditions, such as equipment not being disinfected prior to entering aseptic processing areas, and the presence of difficult-to-clean equipment with air vents and internal fans within the ISO 5 environment, lacking adequate environmental monitoring. A critical finding concerned the inappropriate assignment of Beyond Use Dates (BUDs) for sterile human drug products. The company was found to be setting BUDs that extended beyond failing stability test data for potency and particulate levels in multiple products. Additionally, the facility exhibited poor material flow, with equipment wrappers and used wipes left within the ISO 5 environment during sterile drug production. These observations highlight deficiencies in facility controls, aseptic technique, and quality control. Downing Labs, LLC is required to implement comprehensive corrective actions to address these findings and ensure compliance with good manufacturing practices, thereby safeguarding product quality and patient safety.