Coats International Holdings, Inc – FDA Warning Letter, Sep 18, 2009

On September 1-18, 2009, an FDA inspection of Coats International Holdings, Inc. in Dallas, Texas, revealed multiple violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) for dietary supplements. The firm's Herbalife Ready Herbal Aloe and Herbalife Herbal Aloe Concentrate products were deemed adulterated.

Key deficiencies included: 1. Failure to conduct appropriate identity testing for aloe dietary ingredient (21 CFR 111.75(a)(1)(i)). The firm's proposed (b)(4) and appearance testing and future chromatography plans were deemed inadequate without specific implementation details or alternatives. 2. Lack of documentation for the rationale behind in-process and component specifications to ensure product identity, purity, strength, and composition (21 CFR 111.95(b)(3) and (b)(4)). The firm's HACCP plan and new SOP were not adequately detailed or submitted for evaluation. 3. Failure to follow written procedures for collecting representative samples of components (21 CFR 111.153, 111.155(c)(1)), specifically regarding potassium sorbate and trisodium citrate dihydrate. Revised SOPs lacked assurance of staff training. 4. Inadequate quality control program, including: * No periodic review of instrument calibration records (21 CFR 1