# FDA WARNING_LETTER - Purechempros LLC - November 22, 2022

Source: https://www.keypedia.com/records/warning_letter/purechempros-llc/a6dd5078-7241-44f4-b852-a491d5d6f52c

> FDA WARNING_LETTER for Purechempros LLC on November 22, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Purechempros LLC
- Inspection Date: 2022-11-22
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: On September 1, 2023, the FDA issued a Warning Letter to PureChemPros LLC following an inspection from November 17-22, 2022. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Specific violations include:
1.  **Failure of Quality Control Unit (21 CFR 211.22):** The firm lacked an adequate quality unit to oversee drug manufacturing, including PureCareRx Liquid Hand Sanitizer.
2.  **Inadequate Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to test incoming components for identity, purity, strength, and quality, relying on unvalidated supplier COAs. Water used in manufacturing was also not tested for suitability.
3.  **Lack of Stability Testing (21 CFR 211.137(a)):** The firm failed to implement a stability testing program to support product expiration dates.

Additionally, "35% FOOD GRADE HYDROGEN PEROXIDE" and "3% FOOD GRADE HYDROGEN PEROXIDE" were identified as unapproved new drugs, violating 21 U.S.C. 355(a) and 3

## Related Documents

- [483 - 2022-11-22](https://www.keypedia.com/records/483/purechempros-llc/cdfc66d5-1b51-45a3-a11b-0709c6b5da39)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)
- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/purechempros-llc/caa2b1f2-639f-4e89-acff-b4896f2420b7

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6