Pure Herbs Ltd – FDA Warning Letter, May 31, 2013

The FDA inspected Pure Herbs, Ltd. from April 23 to May 31, 2013, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products adulterated. Additionally, Ginkgo, Gotu Kola, and Chickweed products were found to be misbranded under 21 U.S.C. § 343 due to labeling deficiencies.

Key CGMP violations include: 1. Failure to establish adequate component specifications (21 CFR 111.70(b)). 2. Failure to determine if component specifications are met before use (21 CFR 111.73). 3. Failure to ensure scientifically valid test methods and establish laboratory control processes (21 CFR 111.75(h)(1), 21 CFR 111.315(d)). 4. Failure to establish finished product specifications for identity, purity, strength, composition, and contamination limits (21 CFR 111.70(e)). 5. Failure to examine representative samples of packaged and labeled dietary supplements (21 CFR 111.415(g)). 6. Master Production Records lacking necessary specifications (21 CFR 111.210(h)(1)). 7. Use of inappropriate and non-cleanable equipment (2