Aruba Aloe Balm N.V. – FDA Warning Letter, Nov 16, 2023

The FDA inspected Aruba Aloe Balm N.V. from November 13-16, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, "ISLAND REMEDY ALL-DAY REVITALIZING MOISTURIZER" is misbranded per 21 U.S.C. 352(f)(2).

Key violations include: 1. **Failure to test components (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm did not test incoming raw materials for identity, purity, strength, and quality. Specifically, ethanol containing approximately 4.75% methanol was used in drug products, leading to a recall of hand sanitizers and Alcoholada Gel. Glycerin and propylene glycol were not tested for diethylene glycol (DEG) or ethylene glycol (EG) contamination. The firm's water system for OTC drug production was not validated or adequately monitored for microbiological quality. 2. **Failure to test drug products before release (21 CFR 211.165(a) and 211.165(b)):** OTC drug products lacked adequate testing for active ingredient identity, strength, and microbiological quality prior to release.