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

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