FDA WARNING_LETTER - DC Nutrition, Inc. - June 28, 2012

On June 26-28, 2012, the FDA inspected DC Nutrition, Inc.'s dietary supplement facility, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), causing products to be adulterated. This was a repeat observation from a previous inspection in 2011.

Violations included: 1. **Failure to implement production and process controls (21 CFR 111.55):** No system for quality control operations, including specifications, raw material receipt/testing, or processing controls. The company's response was inadequate, lacking documentation and proposing unacceptable timelines. 2. **Failure to establish and verify finished product specifications (21 CFR 111.70(e), 111.75(c)):** No specifications for identity, purity, strength, and composition of finished dietary supplements, nor verification testing. The response was inadequate, lacking documentation and proposing unacceptable timelines. 3. **Deficient Master Manufacturing Records (MMR) (21 CFR 111.205(b)(1), 111.210):** MMRs lacked specifications, complete component lists, dietary ingredient identity/weight, overage amounts, theoretical yields, packaging descriptions, representative labels, written instructions, sampling procedures, and corrective action plans. The response was inadequate, lacking detail and proposing unacceptable timelines