FDA 483 - Eagle Pharma Outsourcing LLC - May 18, 2018

An FDA inspection conducted at Eagle Pharmacy Inc., an outsourcing facility, from May 1 to May 18, 2018, resulted in a Form FDA 483, detailing significant concerns regarding controls for drug product manufacturing. The observations highlight deficiencies in adherence to established quality standards for drug manufacturing. Key violations include inadequate laboratory controls, specifically the absence of routine testing for preservative content in multi-dose injectable drug products. Additionally, the inspection revealed a lack of appropriate procedures to prevent microbiological contamination, with particular issues in the validation of sterilization processes. This encompassed unvalidated sterilization methods and insufficient record-keeping for validated processes, impacting the assurance of sterility for critical injectable products. Further observations noted deficiencies in maintaining aseptic processing areas, specifically the lack of calibration for vital equipment monitoring environmental conditions such as pressure, temperature, and humidity. Lastly, essential analytical equipment, including the analytical balance, was not adequately maintained or calibrated with certified weights, failing to verify its proper performance for weighing drug components. Eagle Pharmacy Inc. is required to address these observations by implementing comprehensive corrective actions to ensure drug product quality, safety, and compliance with regulatory requirements.