# FDA WARNING_LETTER - Libi Labs, Inc. - April 01, 2013

Source: https://www.keypedia.com/records/warning_letter/libi-labs-inc/4f4f0afb-263a-444b-914b-1b226a1bd05d

> FDA WARNING_LETTER for Libi Labs, Inc. on April 01, 2013. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Libi Labs, Inc.
- Inspection Date: 2013-04-01
- Product Type: Food
- Office Name: Florida District Office
- Summary: The FDA inspected Libi Labs, Inc.'s dietary supplement manufacturing facility in Largo, FL, from March 25 to April 1, 2013, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations render the firm's Green Coffee Bean Capsules and Weightloss Supplement Capsules adulterated under section 402(g)(1) of the Federal Food, Drug and Cosmetic Act. Key violations include the failure to conduct identity testing for dietary ingredient components (21 CFR 111.75(a)(1)(i)), failure to qualify suppliers by confirming the reliability of their Certificates of Analysis (21 CFR 111.75(a)(2)(ii)(A)), and failure to establish component specifications (21 CFR 111.70(b)). Additionally, the firm failed to establish in-process specifications (21 CFR 111.70(c)(1)) and did not prepare or follow written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)). Libi Labs' written responses from April and July 2013 were deemed inadequate, as they lacked sufficient documentation to demonstrate corrective actions or actual compliance with CGMP requirements. The FDA emphasized the firm's responsibility for ensuring product quality and compliance. The company must promptly correct all cited violations and respond within fifteen working days with specific corrective steps and supporting documentation. Failure to comply may lead to legal action, including seizure and injunction, and potential re-inspection fees. The letter also noted the need for stability data to support any expiration dates.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/randall-l-morris/91b75634-8ee0-43bb-a4b4-a37780fa2b45)
- [Kathleen M. Sinninger](https://www.keypedia.com/people/kathleen-m-sinninger/abee8577-ba5d-473f-a8d8-6e60bb1630fb)

Company: https://www.keypedia.com/companies/libi-labs-inc/fb295dcd-9d87-4cda-8248-e9e342bc741e

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9