FDA 483 - PQ Pharmacy LLC - October 27, 2022

On October 11-27, 2022, the FDA inspected PQ Pharmacy LLC, an outsourcing facility (503B) located at 15215 Technology Dr, Brooksville, FL 34604-0690. The inspection, led by Investigators Joanne E King and Kayla V Sprague, resulted in six observations detailed in Form 483, issued to President Hale N. Dimetry on November 17, 2022.

Key observations include: 1. **Quality Control Unit Deficiencies:** The quality control unit (QCU) lacked authority to fully investigate errors and did not fully investigate laboratory test results before releasing finished drug products. Specifically, assay testing for Prednisolone Sodium Phosphate/Moxifloxacin HCL/Bromfenac 1%/0.5%/0.09% and Prednisolone Sodium Phosphate/Moxifloxacin HCL 1%/0.5% ophthalmic solutions was performed using an unvalidated test method, with lots distributed prior to method validation on October 27, 2022. 2. **QCU Procedure Non-Adherence:** The QCU's responsibilities and procedures were not fully followed. The beyond use date (BUD) for Mitomycin (1mg/1ml) in 50 ml syringe was extended multiple times (from 60 to 90,