# FDA WARNING_LETTER - Columbine Specialty Products Inc. - December 10, 2010

Source: https://www.keypedia.com/records/warning_letter/columbine-specialty-products-inc/39e24758-bfe8-4ac2-96b5-3eb84726df36

> FDA WARNING_LETTER for Columbine Specialty Products Inc. on December 10, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Columbine Specialty Products Inc.
- Inspection Date: 2010-12-10
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: On December 1-10, 2010, the FDA inspected Columbine Specialty Products Inc., a dietary supplement manufacturer, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated under 21 U.S.C. § 342(g)(1). The inspection also revealed one product, (b)(4), was misbranded under 21 U.S.C. § 343(e).

Key violations include:
1.  **Lack of Finished Product Specifications:** Failure to provide records for established product specifications (identity, purity, strength, composition) for finished dietary supplements, including (b)(4) products, as required by 21 CFR 111.70(e).
2.  **No Finished Product Verification:** Failure to verify finished batches meet specifications; the firm admitted to no finished goods testing (21 CFR 111.75(c)). The firm's contract manufacturer status does not exempt it from these requirements.
3.  **Missing Component Specifications:** Failure to make and keep records of established component specifications to ensure dietary supplement quality (21 CFR 111.95(b)(1), 111.70(b)(1), (b)(2)).
4.  **Incomplete Master Manufacturing Records (MMR):** MMR

## Related Officers

- [Director](https://www.keypedia.com/people/howard-e-manresa/f356641d-5846-4f54-a755-2aba7c43be1a)

Company: https://www.keypedia.com/companies/columbine-specialty-products-inc/55438d08-534e-4f00-be5c-4a020ed11a46

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861