FDA 483 - PQ Pharmacy LLC - April 04, 2025

On April 4, 2025, FDA Compliance Officer Jose R. Lopez issued a Form 483 to Hale Dimetry, President of PQ Pharmacy LLC, an outsourcing facility located at 15215 Technology Dr, Brooksville, FL. The inspection, conducted from March 25 to April 4, 2025, identified four observations related to production controls, aseptic processing, environmental monitoring, and investigation procedures.

**Observation 1: Inadequate Production and Process Controls** PQ Pharmacy LLC failed to establish adequate written procedures for production and process controls. * **Hold Time Studies:** The firm did not conduct hold time studies to justify bulk solution bag hold times for products like Prednisolone Sodium Phosphate/Bromfenac, Mitomycin, Semaglutide, Tirzepatide, and Moxifloxacin HCl/Bromfenac. Batches with hold times were not included in stability studies, and no studies defined storage conditions, container closure integrity, chemical stability, or sampling timepoints. * **Extended Hold Times:** The firm routinely (b)(4) bulk bags to extend hold times beyond the (b)(4) day limit without validating the process or assessing its impact on product stability, quality, and shelf life. This occurred approximately 11 times between October 2024 and March 2025, including instances due to particulate contamination, (b)(4) failures, and microbiological