American Cleaning Solutions – FDA Warning Letter, Mar 28, 2022

The FDA inspected American Cleaning Solutions' drug manufacturing facility from March 7-28, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm manufactures OTC hand sanitizers and non-drug products like insecticides using the same equipment, posing cross-contamination risks.

Violations include: 1. **Failure to establish and follow written cleaning and maintenance procedures (21 CFR 211.67(b)):** Inadequate cleaning procedures, lack of cleaning documentation, and equipment in disrepair (rust, dirt, grease) were observed. 2. **Failure to establish adequate written production and process control procedures (21 CFR 211.100(a) and (b)):** Processes were not validated, equipment not qualified, and batch records inconsistently reflected formulations (e.g., using ethanol not listed on labels, using non-purified water despite labels). 3. **Failure to test incoming components and qualify suppliers (21 CFR 211.84(d)(1) and (2)):** No identity testing for incoming components, reliance on unqualified supplier COAs, and no evidence of raw material testing or supplier qualification. 4. **Quality control unit failure (21 CFR 211.22):** The quality unit did not adequately oversee manufacturing operations.

Additionally, Secure Hand Sanitizer was found to be adulterated