FDA 483 - Qualgen, LLC - September 17, 2015

This FDA Form 483 was issued to Qualgen LLC, an outsourcing facility located at 14844 Bristol Park Blvd, Edmond, OK 73013, following an inspection from August 24 to September 17, 2015. Shaun P. Riney, General Manager, was the recipient.

The inspection revealed 14 observations related to deficient quality systems and manufacturing practices for testosterone and estradiol pellets:

1. **Contamination Prevention Deficiencies:** Lack of meaningful environmental monitoring data, absence of established integration limits for environmental and personnel monitoring, and failure to investigate excursions. Personnel glove monitoring was not daily during production, and pressure differential losses in cleanrooms were not investigated. 2. **Sterilization Process Validation:** Procedures for preventing microbiological contamination of sterile drug products lacked validation of the sterilization process, evidenced by four sterility failures in two months. 3. **Container/Closure Processing:** Cleaning, sterilization, and depyrogenation processes for stoppers and vials were not validated. 4. **Facility Construction:** The ISO 8 Prep Room floor had unsealed holes, the sink's plumbing allowed airborne contaminants, and ceiling panels in cleanrooms had gaps, allowing direct access to unclassified areas and collection of particulates. 5. **Discrepancy Investigations:** Failure to thoroughly review unexplained discrepancies, including sterility failures and out-of-specification potency results for Lot #A017 and