FDA 483 - PQ Pharmacy LLC - October 27, 2022

PQ Pharmacy LLC, an outsourcing facility in Brooksville, FL, was cited for significant quality control and compliance issues during an FDA inspection. The firm failed to validate test methods, properly investigate out-of-specification results, and adhere to established hold times and stability programs for drug products. Additionally, the facility did not submit required reports to the FDA identifying compounded drugs.