FDA 483 - Premier Pharmacy Labs Inc - May 09, 2014

The FDA Form 483 details numerous deficiencies at a drug compounding facility. Key issues include the lack of validation for sterilization processes for drug products like Testosterone, Lidocaine, and Bupivacaine, and the absence of established procedures for preventing microbiological contamination. Aseptic techniques were not followed, with technicians failing to sanitize materials before placing them in the ISO 5 hood, and leaving uncapped vials open. Time dependency requirements for repackaging sterile drug products (e.g., Avastin) were not established.

Media fills were deficient, not accurately simulating production conditions, using inappropriate vial sizes, not demonstrating lengthy processes, lacking simulations for syringes/droppers, and not accounting for interruptions. Gowning procedures were unwritten and qualifications not conducted, leading to inconsistent practices such as inadequate apparel sizing, touching sterile garments with street clothes, and opening sterile bags before handwashing.

Environmental monitoring was inadequate, lacking dynamic active microbial air monitoring, non-viable particle monitoring, and daily personnel monitoring. Sterility testing was flawed; method suitability testing was not performed, raw data was recorded on unprotected spreadsheets by untrained staff, growth promotion testing used unsuitable strains, and positive controls were frequently negative. Sampling plans were not consistently followed, and scientific rationale for endotoxin testing was absent.

Aseptic processing areas lacked dynamic airflow pattern studies and continuous air pressure differential monitoring, with uncalibrated gauges. Cleaning and disinfection procedures were not assessed for efficacy, and sporicidal agents were not routinely used.