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

Source: https://www.keypedia.com/records/warning_letter/bodywell-natural-skin-care-inc/748a1dbd-ec91-4035-92f0-5176a905e719

> FDA WARNING_LETTER for Bodywell Natural Skin Care Inc. on February 05, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bodywell Natural Skin Care Inc.
- Inspection Date: 2024-02-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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))

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Bryce Hammer](https://www.keypedia.com/people/bryce-hammer/57f60d9e-a5f7-4ac4-99d1-c19a1ff8417f)

Company: https://www.keypedia.com/companies/bodywell-natural-skin-care-inc/5d9f9d09-ee2a-4d61-ab73-adf3f7d3daa6

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c