FDA 483 - JMA Partners - April 20, 2018

During an inspection conducted from April 2 to April 20, 2018, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Guardian Pharmacy Services, a producer of sterile and non-sterile drug products in Dallas, TX. The inspection revealed numerous significant deviations from Current Good Manufacturing Practices (CGMP), many of which were repeat observations.Key issues identified include critical deficiencies in environmental control, such as infrequent monitoring of cleanroom conditions and personnel, lack of proper semi-annual cleanroom recertification, and inadequate cleaning and disinfection procedures utilizing non-sterile agents and unvalidated processes. The firm failed to document environmental airflow studies and used equipment not easily cleanable, posing contamination risks. Significant lapses were noted in quality control, with a lack of investigation into environmental excursions and batch failures, including products with confirmed growth or insufficient potency that were still distributed. The validation of sterilization processes, including media fills and autoclave/dry-heat cycles, was found deficient. Furthermore, the company did not conduct essential laboratory testing for finished products, such as bacterial endotoxin, sterility for terminally sterilized products, potency, and microbial enumeration, and lacked a scientific basis for establishing product beyond-use dates. Procedures for handling consumer complaints were also not consistently followed, and calibration records for critical equipment were not maintained.To regain compliance, Guardian Pharmacy Services is required to implement comprehensive corrective and preventive actions, including validating their aseptic processes, environmental controls, and sterilization cycles. They must establish and follow robust testing programs for product quality and stability, thoroughly investigate all discrepancies, and ensure adherence to all written procedures and regulatory requirements to safeguard drug product quality and patient safety.