Qualgen FDA 483 Cites Quality Issues
FDA inspectors cited Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures during a recent inspection, including inadequate controls to prevent cross-contamination of hazardous drugs and repeated lapses previously flagged by the agency. According to an FDA Form 483 issued at the conclusion of the inspection conducted from 8/19 to 9/4/2025, investigators documented at least five major categories of violations at Qualgen’s Edmond, OK facility, which compounds implantable testosterone and estradiol pellets.
Among the most serious findings, inspectors said the firm lacked adequate physical and procedural separation to prevent mix-ups and cross-contamination when manufacturing hazardous hormone products. FDA investigators observed that testosterone and estradiol pellets were produced in adjacent cleanrooms with shared ante rooms that were not cleaned between runs, despite the rooms being maintained under positive pressure. The agency also said Qualgen could not demonstrate that its cleaning agents and procedures were effective at deactivating hazardous drug residues.
The FDA further cited the company for failing to clean shared equipment in accordance with its own procedures and for storing equipment used in both testosterone and estradiol production in gowning areas, raising additional contamination risks.
Quality system failures featured prominently in the inspection report. The FDA said responsibilities and procedures for the quality control unit were not fully defined in writing or consistently followed, marking a repeat observation from a prior inspection conducted in early 2024. Inspectors documented incomplete cleaning records, deviations from visual inspection procedures for finished vials, and calibration practices that did not meet the firm’s own specifications.
In one case, investigators said digital calipers and balances used to measure pellet dimensions and weigh active ingredients were calibrated at fewer points or outside required ranges, even though the equipment was used in active production. The agency also cited incomplete or missing investigations into customer complaints, including one alleging infections in patients who received testosterone pellets.
The FDA additionally faulted Qualgen for not identifying or correcting a critical cleanroom failure. Inspectors found that a HEPA filter in an ISO-classified testosterone production room had no airflow at the time of certification in May 2025, yet the room continued to be used for granulation and compression operations. Quality and production managers were unaware the filter was not functioning, and the firm could not determine when airflow had been cut off.