# FDA WARNING_LETTER - Raca Enterprises, Inc. dba Life Cycle Herbal Products - August 20, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/raca-enterprises-inc-dba-life-cycle-herbal-products/981a8c58-c2e2-4305-95b0-9fb386564d16

> FDA WARNING_LETTER for Raca Enterprises, Inc. dba Life Cycle Herbal Products on August 20, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Raca Enterprises, Inc. dba Life Cycle Herbal Products
- Inspection Date: 2012-08-20
- Product Type: Food
- Office Name: Department of Health and Human Services
- Summary: 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

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- [Director](https://www.globalkeysolutions.net/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.globalkeysolutions.net/companies/raca-enterprises-inc-dba-life-cycle-herbal-products/46ec227b-8b0b-4cd4-862e-c05500c5830c

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