FDA 483 - Qualgen LLC - September 13, 2018

This FDA Form 483 details numerous deficiencies at a facility manufacturing Testosterone and Estradiol pellets.

**Facility and Operations:** The firm produces Testosterone and Estradiol pellets, including Testosterone 100mg, Estradiol 6mg, Estradiol 15mg, Estradiol 10mg, Testosterone 200mg/Anastrozole 20mg. Operations involve ISO 5 hoods (Biological Safety Cabinets - BSCs), ISO 7 cleanrooms, ISO 8 Prep Room, and ISO 8 Ante Room.

**Violations and Observations:** * **Inadequate Investigations:** Failure to thoroughly investigate unexplained discrepancies, batch failures, and out-of-specification results. * Eight environmental monitoring action level excursions (April 2017-July 2018) in ISO 5 hoods (3 in Testosterone BSC, 5 in Estradiol BSC) lacked identified root causes and comprehensive reviews. * An April 23, 2018, ISO 7 surface excursion (TNTC CFUs) lacked investigation and isolate identification. * Rejected Testosterone 100mg pellets (Lot D048, Feb 2018) due to "poor quality" lacked investigation. * A May 3, 2018, gowning qualification failure lacked investigation and isolate identification. *