FDA WARNING_LETTER - Drug Depot, LLC., dba APS Pharmacy - January 22, 2016

The FDA issued a Warning Letter to Drug Depot, Inc., dba APS Pharmacy, following an inspection from December 15, 2015, to January 22, 2016, prompted by a MedWatch report concerning a testosterone drug. The inspection revealed serious deficiencies in the production of sterile drug products, rendering them adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Key violations included the use of non-pharmaceutical grade filters labeled "not intended for use in direct patient care," exposure of partially-stoppered vials to less than ISO 5 quality air, use of non-sterile water to wash vials and stoppers, and failure to depyrogenate stoppers. Poor aseptic practices were observed, such as transferring items without prior disinfection and an operator placing an exposed head inside the ISO 5 hood. The firm also used a non-sterile disinfectant for the ISO 5 hood and failed to demonstrate adequate protection of ISO 5 areas through appropriate studies.

The FDA reviewed the firm's responses but found them lacking supporting documentation for corrective actions, such as design and smoke studies for a new ISO 5 working zone, test protocols for filter safety, and dynamic smoke study reports. The letter emphasizes that adulteration due to insanitary conditions applies regardless of compliance with section 503A. The firm must promptly correct all violations and provide written notification with supporting documentation within fifteen