FDA 483 - Auro Pharmacies, Inc. - November 05, 2015

The FDA Form 483 details numerous deficiencies at a firm manufacturing sterile drug products. Key issues include a lack of endotoxin testing for released products (e.g., Ascorbic Acid, Glutathione) and sublots, and unvalidated endotoxin test methods. Sterility test methods were inadequate, lacking suitability determination for products like Ascorbic Acid and Glutathione, and an insufficient number of containers were tested.

Process simulations were deficient, with no growth promotion for media, and simulations were not conducted for lyophilization or the preparation of vials and stoppers. Lyophilization processes for HCG Injection and Glutathione Lyophilize were not validated.

Aseptic processing practices were compromised by operator behavior, including touching surfaces without sanitizing gloves and leaning into the laminar flow hood. Environmental monitoring was inconsistent, with a gap in viable air monitoring and no established alert/action limits for personnel monitoring. Personnel monitoring was not performed after each operational shift.

The firm lacked documented investigations for out-of-specification endotoxin results and quality-related events (e.g., suspected high endotoxin levels, patient reactions). Stability testing programs were absent for products like Ascorbic Acid 500mg/ml Injection, and ongoing stability programs were not in place to ensure potency and sterility throughout the 6-month shelf life. Preservative effectiveness determination was not conducted for products containing preservatives, and preservative concentration was not assayed. The firm also lacked data to support the storage duration