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

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