Good Herbs, Inc. – FDA Warning Letter, Jan 12, 2012

The FDA inspected Good Herbs Inc. from November 2011 to January 2012, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products adulterated. Deficiencies included failure to establish and maintain specifications for manufacturing processes, dietary ingredient identity, and finished product identity, purity, strength, and composition. The firm also failed to conduct identity testing for dietary ingredients. Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) were incomplete, lacking critical information such as equipment identity, cleaning dates, component weights, yield documentation, and real-time performance records. Additionally, the company lacked written procedures for quality operations and packaging/labeling. Furthermore, the FDA reviewed the company's "A Practical Guide to Herbs" book, which contained therapeutic claims for several products (e.g., AquaActive Tablets, Capsicum 90, IMB-T PLUS, HR-2, Olive Leaf, PARA-2-L, PO-K) for treating various diseases. These claims establish the products as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug and Cosmetic Act, violating sections 301(d) and 505(a). The products are also misbranded under section 502(f)(1) due to inadequate directions for use for conditions not amenable to self-diagnosis. Good Herbs Inc. must promptly correct all violations within fifteen working days, providing documentation of corrective actions, or face potential legal action, including seizure and injunction.