FDA 483 - Qualgen, LLC - March 19, 2024

The FDA inspection revealed significant deficiencies across multiple quality system areas at the facility manufacturing hormone pellets.

**Facility and Operations:** The facility manufactures hormone pellets, including Testosterone and Estradiol variants. Operations involve pellet pressing, sterilization, and packaging in ISO 7 and ISO 8 cleanrooms.

**Violations and Observations:** * **Quality Control Unit Deficiencies (Observation 1):** The Quality Control Unit (QCU) is not fully following its responsibilities and procedures. This includes inadequate documentation, investigation, tracking, and trending of product complaints (detailed in Observation 2). Root causes for deviations are not always identified or documented, and investigations often fail to include all related issues (detailed in Observation 3). A CAPA (22-0017) addressing insufficient work order information was closed without documented effectiveness checks, and work orders continue to lack sufficient detail on activities performed, including maintenance on pellet presses. This is a repeat observation. * **Complaint Handling (Observation 2):** Procedures for handling complaints are not followed. At least 23 reports of broken pellets were not documented or investigated since September 2022. A decision not to investigate Complaint #CIN-22-055 (broken pellets) lacked QA review and approval. The firm is not tracking and trending all complaints as required by SOP QG-1069, and trending of broken pellets only considers the number of complaints, not the number of broken pellets