Gordon Laboratories Inc – FDA Warning Letter, Mar 10, 2022

The FDA issued a Warning Letter to Gordon Laboratories Inc. on August 17, 2022, following an inspection from February 8 to March 10, 2022, and prior FDA testing. The facility, a manufacturer of OTC drug products including consumer hand sanitizers, was found to have produced adulterated drug products under section 501(a)(2)(B) of the FD&C Act.

FDA testing of "artnaturals SCENT FREE HAND SANITIZER" revealed unacceptable impurity levels: approximately 15 ppm benzene, 146 ppm acetaldehyde, and 469 ppm acetal. These findings led to a voluntary nationwide recall of two batches on October 26, 2021, expanded to at least 38 additional batches on April 22, 2022.

Key CGMP violations cited include: 1. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** Inadequate investigation into the root cause of benzene, acetal, and acetaldehyde impurities, and lack of testing for other impacted batches. Also, insufficient investigation into microbiological excursions in the water system and missing water quality data before July 2021. 2. **Failure to test components (21 CFR 211.84(d)(1) and 211.84(d)(2)):**