Raca Enterprises, Inc. dba Life Cycle Herbal Products – FDA Warning Letter, Aug 20, 2012

On December 14, 2012, the FDA issued a Warning Letter to Raca Enterprises, Inc., dba Life Cycle Herbal Products, following an inspection from August 7-20, 2012. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated under 21 U.S.C. § 342(g)(1).

Key violations include: 1. **Failure to Reject Non-Conforming Product:** Quality control failed to reject a dietary supplement lot that tested positive for E. coli, shipping it with a Certificate of Analysis (COA) stating negative results. Subsequent retesting was done only after FDA intervention. 2. **Inadequate Quality Control Procedures:** The firm lacked written procedures for quality control operations, including material review, disposition decisions, and approving/rejecting reprocessing. 3. **Failure to Verify Dietary Ingredient Identity:** The firm did not conduct identity testing for dietary ingredients like (b)(4) Powder, (b)(4) Powder, and (b)(4) Powder. 4. **Inadequate Component Supplier Qualification:** The firm failed to confirm the identity of other components or qualify suppliers by confirming COA results, relying instead on supplier history. 5. **Lack of Master Manufacturing Records (MMRs):** The firm did not prepare and follow