# FDA WARNING_LETTER - Ultra Chem Labs Corporation - July 27, 2022

Source: https://www.keypedia.com/records/warning_letter/ultra-chem-labs-corporation/442425fe-cb2a-4a9e-9858-c43a78465381

> FDA WARNING_LETTER for Ultra Chem Labs Corporation on July 27, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ultra Chem Labs Corporation
- Inspection Date: 2022-07-27
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Ultra Chem Labs Corporation's drug manufacturing facility from July 25-27, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug product adulterated. The product, PROTON ARMOR ANTI-MICROBIAL ALCOHOL-FREE FOAMING HAND SANITIZER, is also an unapproved new drug and misbranded.

Key violations include:
1. **Quality Control Unit Failure:** The quality unit approved an active ingredient, ULS 8357, containing methanol, without suitability evaluation. Finished products contained unacceptable methanol levels (0.13% to 0.33%), a toxic substance. The firm failed to test for methanol and lacked adequate quality systems.
2. **Inadequate Release Testing:** The firm only conducted pH, viscosity, and clarity testing, failing to perform full release testing, including microbial, strength, and identity testing of the active ingredient.
3. **Insufficient Component Testing:** No testing was performed on components like benzalkonium chloride and ULS 8357. The firm accepted components without validating supplier test analyses or obtaining Certificates of Analysis.

The hand sanitizer is an unapproved new drug because it's not generally recognized as safe and effective (GRASE). It contains ULS 8357 (methanol), an unpermitted active ingredient, and makes unapproved "24 HOUR GERM PROTECTION" claims. It's misbranded

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/ultra-chem-labs-corporation/d02ee759-573c-43d4-bf66-0bdaa6c3e712

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