FDA 483 - Wedgewood Village Pharmacy, LLC - September 29, 2015

The FDA inspection of the facility revealed significant deficiencies in quality control and aseptic processing. The firm failed to ensure appropriate laboratory determination of identity and strength for active ingredients before drug product release, a repeat observation from a February 2013 inspection. Corrective and preventative actions were not fully implemented, as the firm continues to formulate drug products without verifying Certificates of Analysis (C of As) and has not fully qualified suppliers by periodically analyzing Active Pharmaceutical Ingredient (API) lots or performing unique identity tests. Only a small percentage of finished products are tested for potency.

A critical finding involved a June 2013 recall of veterinary drug products labeled as containing Trimeprazine (as Tartrate) 5mg/capsule (e.g., Batch ID 200-20120620) which were found to contain no Trimeprazine Tartrate USP, but rather tartaric acid. This issue was only detected when the firm sought to extend the API's shelf life.

Aseptic processing areas are deficient in environmental monitoring. The current monitoring system, including gloved hand monitoring once every six months, lack of gowning attire monitoring, non-viable particle monitoring once every six months, and viable air/surface monitoring once a month, is statistically insufficient given the processing of approximately 20 batches daily. Procedures to prevent microbiological contamination are not established, with media fills not factoring in complex or worst-case conditions, and smoke studies not performed