FDA WARNING_LETTER - PQ Pharmacy LLC - April 04, 2025

The FDA issued a Warning Letter to PQ Pharmacy, LLC following an inspection from March 25 to April 4, 2025. The company, registered as an outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), failed to meet critical conditions for its drug products to qualify for exemptions from certain provisions of the FDCA. Key violations included the omission of established drug names on product labels and inadequate adverse event reporting procedures, specifically regarding the definition of a "serious" adverse event as per 21 CFR 310.305(b). Furthermore, the inspection revealed serious deficiencies in practices for producing sterile drug products, rendering them adulterated under FDCA Section 501(a)(2)(A) due to insanitary conditions. Operators were observed resting arms on work surfaces and disrupting "first air" in aseptic areas, and the firm failed to conduct adequate smoke studies. The company also violated Current Good Manufacturing Practice (CGMP) regulations, leading to adulteration under FDCA Section 501(a)(2)(B). These CGMP failures included inadequate written procedures for production and process control, insufficient procedures to prevent microbiological contamination and validate aseptic processes, a deficient environmental monitoring system, and a failure to thoroughly investigate unexplained discrepancies. PQ Pharmacy, LLC is required to implement comprehensive corrective actions to address these violations and ensure compliance with the FDCA and CGMP regulations to protect public health.