FDA 483 - Drug Depot, LLC., dba APS Pharmacy - January 22, 2016

The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products including Methylcobalamin, HCG, Testosterone Cypionate, and Sermorelin.

Key violations include the lack of validation for sterilization processes for drug products, container/closures, and their storage hold times. Calibration procedures and documentation for equipment, including that used for glassware and finished product vials, are absent. Partially stoppered vials are exposed to less than ISO 5 air during filling, and personnel fail to sanitize items before placing them into the laminar flow hood. Personnel also place their heads inside the laminar flow hood during sterile drug preparation.

Media fills are deficient, not accurately simulating production or challenging conditions, and specific media fill data for HCG vial filling is missing. Environmental monitoring is inadequate, with air sampling (viable and non-viable) and surface sampling in classified areas only performed monthly, not daily. Continuous or periodic air pressure differential monitoring is not conducted. Dynamic airflow pattern studies (smoke studies) have not been performed in laminar flow hoods.

Personnel monitoring, including fingertip sampling and gowning material sampling, is not conducted daily. Non-sterile disinfectants are used, and no sporicidal agent is employed for classified areas. Disinfectant efficacy documentation is lacking. Gowning qualifications are not conducted, and non-sterile gowning components are used. Personnel were observed sliding hands on gowns after hanging them.

Sterility testing is not validated for interference or low-level organism detection,