FDA WARNING_LETTER - Bodywell Natural Skin Care Inc. - February 05, 2024

The FDA issued a Warning Letter to Bodywell Natural Skin Care Inc. on March 27, 2024, following a review of records requested on February 8, 2023, under section 704(a)(4) of the FD&C Act. The company, an OTC drug product manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test component identity (21 CFR 211.84(d)(1) and (d)(2))**: The firm did not adequately test incoming components, including ethanol for methanol, relying on supplier COAs without validation. 2. **Inadequate finished product testing (21 CFR 211.165(a))**: The company failed to conduct appropriate laboratory determinations for final specifications, including active ingredient identity and strength, prior to release. 3. **Lack of adequate production and process control procedures (21 CFR 211.100(a))**: Manufacturing processes were not validated, with the firm stating it had not validated procedures with any source other than Health Canada reviews. 4. **Insufficient batch production and control records (21 CFR 211.188(b))