# FDA WARNING_LETTER - Denison Pharmaceuticals, LLC - February 09, 2023

Source: https://www.keypedia.com/records/warning_letter/denison-pharmaceuticals-llc/c2965870-94dc-43e6-b329-b059c7876903

> FDA WARNING_LETTER for Denison Pharmaceuticals, LLC on February 09, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Denison Pharmaceuticals, LLC
- Inspection Date: 2023-02-09
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: The FDA issued a Warning Letter to Denison Pharmaceuticals, LLC, following an inspection from January 5 to February 9, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations. The facility's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include:
1.  **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate lubricant contamination (non-food grade lubricant used for months, impacting over 60 batches including infant products), multiple foul odor complaints for a product (with TNTC yeast and mold, and *Staphylococcus epidermis* identified, yet deemed "fit for use" without market action), and numerous microbiological excursions in the purified water system (TNTC bacteria, lack of root cause, and impact assessment).
2.  **Lack of Component Identity Testing (21 CFR 211.84(d)(1)):** Failure to test high-risk components like glycerin and propylene glycol for diethylene glycol (DEG) and ethylene glycol (EG) contamination, which can cause lethal poisoning.
3.  **Unvalidated Test Methods (21 CFR 211.165(e)):** Failure to validate alternative rapid microbiological test methods, specifically the (b)(4) system, which showed failing results for total count and objectionable microorganisms (e.g

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## Related Officers

- [Micah S. Gerchenson](https://www.keypedia.com/people/micah-s-gerchenson/2d75811e-e137-4d8d-b317-9488176f9764)
- [Keith Page](https://www.keypedia.com/people/keith-page/84a4f80c-700d-472b-9dae-9769e8672d60)
- [Program Division Director](https://www.keypedia.com/people/lisa-m-harlan/e5d04349-6dd6-4f08-b31f-bf719c8413ab)
- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

Company: https://www.keypedia.com/companies/denison-pharmaceuticals-llc/c217e50a-bd7d-49c3-8f66-2bf20a1c71ec

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02