FDA 483 - Qualgen, LLC - May 10, 2017

An FDA inspection of Qualgen, LLC, an outsourcing facility located in Edmond, OK, was conducted from April 17 to May 10, 2017. The inspection revealed significant deviations from regulatory requirements for sterile drug manufacturing, necessitating comprehensive corrective actions. Key observations included a recurring failure to thoroughly investigate unexplained discrepancies, such as multiple sterility failures for testosterone and estradiol pellets in 2016 and 2017, as well as environmental monitoring excursions and HEPA filter leaks. The firm's investigations were often incomplete, lacking documented root cause analyses or product impact assessments.

Furthermore, procedures to prevent microbiological contamination were deemed inadequate, with a lack of validation for the sterilization process of all pellet products. Critical processes like smoke studies were not representative of actual operations, and observations of improper handling of sterile components and unsanitary operator practices were noted. Deficiencies in maintaining controlled cleanroom environments were also identified, including incomplete third-party certification reports, incorrect personnel sampling techniques, numerous personnel monitoring excursions, undocumented pressure differentials, and the presence of rust on equipment in a cleanroom.

The inspection also found a lack of established and followed written procedures for in-process controls, specifically regarding the absence of statistical justification for sample sizes and the cessation of documenting individual pellet weight values. Finally, the firm failed to ensure appropriate laboratory testing for objectionable microorganisms; the sterility test methods used by their third-party vendor for both release testing and sterilization process validation were not validated, and bioburden determination was insufficient. Qualgen, LLC is required to address these systemic issues by enhancing its quality systems, validating critical processes, and improving environmental and personnel controls to meet federal regulatory standards for sterile drug production.