FDA 483 - JMA Partners - October 21, 2016

An FDA inspection conducted from September 12 to October 21, 2016, at Guardian Pharmacy Services, a producer of sterile and non-sterile drug products, identified significant deficiencies in their manufacturing processes and quality systems. The inspection highlighted a lack of validation for critical sterilization processes, including media fills that did not accurately simulate routine production and unvalidated terminal sterilization methods for various injectable drugs. The company also failed to perform finished product sterility testing for terminally sterilized products.

Environmental control was a major concern, with the routine use of non-sterile disinfectants and wipes in aseptic areas, absence of a sporicidal agent, and inadequate environmental and personnel monitoring during sterile operations. Furthermore, Guardian Pharmacy Services demonstrated a failure to thoroughly investigate deviations, such as environmental monitoring excursions and endotoxin failures, or to consistently document critical process checks like bubble point testing.

Facility and equipment issues included a difficult-to-clean laminar flow hood and the co-mingling of hazardous and non-hazardous drug preparation. Complaint handling procedures were found to be deficient, with undocumented investigations into product defects and a failure to report adverse events to the FDA. These observations indicate non-compliance with fundamental Good Manufacturing Practices for sterile drug production. Guardian Pharmacy Services must implement comprehensive corrective actions to validate all sterile processes, enhance environmental controls, ensure thorough investigations of all discrepancies, and establish robust complaint handling and adverse event reporting systems to safeguard product quality and patient safety.