FDA 483 - PQ Pharmacy LLC - June 01, 2026

From April 20 to June 1, 2026, the FDA inspected PQ Pharmacy LLC, an outsourcing facility located in Brooksville, Florida. The resulting inspection report identifies several significant safety and quality control violations that could compromise the sterility of the firm’s drug products. Key issues include inadequate validation of aseptic manufacturing processes and a failure to follow internal protocols after contamination was detected during simulation tests. Additionally, the facility failed to properly qualify and maintain critical equipment, such as HVAC and HEPA filtration systems, leading to repeated environmental control failures. The inspection also highlighted a lack of thorough investigations into product defects, sterility failures, and consumer complaints. In many cases, the company attributed errors to individual staff members without investigating broader technical or systemic causes. Furthermore, the quality unit lacked written procedures for verifying critical data, failed to perform necessary electronic data backups, and did not conduct required identity testing for certain raw materials. Many of these findings are repeat violations from a 2025 FDA warning letter, indicating persistent non-compliance with the regulatory framework governing outsourcing facilities under the Federal Food, Drug, and Cosmetic Act. While the report does not represent a final agency determination, PQ Pharmacy LLC is required to respond in writing, detailing the corrective actions they have taken or plan to implement to address these safety concerns.