FDA WARNING_LETTER - Horizon Tool Inc. - January 16, 2025

On June 6, 2025, the FDA issued a Warning Letter to Horizon Tool Inc. following an inspection from January 14-16, 2025, at their Greensboro, NC drug manufacturing facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products, specifically antibacterial soaps like AllShield E2 Sanitizing Hand Soap, adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to conduct appropriate microbiological testing (21 CFR 211.165(b)):** Horizon Tool Inc. did not perform required microbiological testing for AllShield E2 Sanitizing Hand Soap, lot 25009, and lacked established product specifications. Their response was inadequate, failing to provide sufficient details or a retrospective risk assessment for distributed batches. 2. **Failure to establish a stability testing program (21 CFR 211.166(a)):** The firm admitted to lacking a stability testing program for AllShield E2 Sanitizing Hand Soap, meaning there's no scientific evidence to support product quality throughout its shelf-life. Their response was inadequate due to insufficient detail and lack of a retrospective risk assessment. 3. **Failure to test incoming components for identity and conformity (21 CFR 211.84(d)(1) and