# FDA 483 - Qualgen LLC - September 13, 2018

Source: https://www.keypedia.com/records/483/qualgen-llc/f752d77c-34db-47e5-802a-843e3399a02f

> FDA 483 for Qualgen LLC on September 13, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qualgen LLC
- Inspection Date: 2018-09-13
- Product Type: Drugs
- Office Name: Dallas District, Fort Worth Resident Post
- Summary: 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.
    *

## Related Documents

- [483 - 2018-09-13](https://www.keypedia.com/records/483/qualgen-llc/853b74b8-eb52-413e-a6d9-a637735a2e24)
- [483 - 2021-06-15](https://www.keypedia.com/records/483/qualgen-llc/91817dba-fdaf-46f1-82e8-c835395432da)

## Related Officers

- [Cornerstone Brands Inc.](https://www.keypedia.com/people/lisa-whitt/6c1ca4bf-d015-4dc0-8f95-dfb72d190b31)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/qualgen-llc/8fddec17-7755-47e6-b78b-5b640deb09ce

Office: https://www.keypedia.com/offices/dallas-district-fort-worth-resident-post/4c0a9dac-ff7f-49c2-9f90-aa7537236b2a