# FDA WARNING_LETTER - Libby Laboratories, Inc. - March 14, 2025

Source: https://www.keypedia.com/records/warning_letter/libby-laboratories-inc/84fb09cf-2a95-42d1-a6b4-c5a988838f10

> FDA WARNING_LETTER for Libby Laboratories, Inc. on March 14, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Libby Laboratories, Inc.
- Inspection Date: 2025-03-14
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On June 27, 2025, the FDA issued a Warning Letter to Libby Laboratories, Inc. following an inspection from March 11-14, 2025, at their Berkeley, California drug manufacturing facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products 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))**: Libby Laboratories released OTC sunscreen and antiseptic drug products, including one distributed to a children's hospital, without testing for objectionable microorganisms. Their response, claiming bactericidal ingredients negated the need for testing, was deemed inadequate, lacking scientific basis and retrospective testing.
2.  **Failure to verify component identity and validate supplier analyses (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not perform adequate identity testing for components like (b)(4) and (b)(4), relying on supplier Certificates of Analysis (COA) without validation. They also used grocery store-purchased (b)(4) with only organoleptic assessment, failing to use purified water and test high-risk components like (b)(4) and (b)(4) for hazardous impurities.

## Related Documents

- [483 - 2025-03-14](https://www.keypedia.com/records/483/libby-laboratories-inc/c6bc5f41-1858-4753-b837-5a1c0639d3bb)

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Emily Wu](https://www.keypedia.com/people/emily-wu/99c14d7f-b7cc-4364-a43a-5f9fed918fab)

Company: https://www.keypedia.com/companies/libby-laboratories-inc/9383702d-87c4-47f8-81dd-08793c3400e1

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