FDA WARNING_LETTER - Teeter Creek Herbs, Inc - February 11, 2013

On January 31-February 11, 2013, the FDA inspected Teeter Creek Herbs, Inc.'s dietary supplement manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplements adulterated under Section 402(g)(1) of the Act.

Additionally, product labeling, including their website, showed that Lymphaid, Astragalus, Pau d Arco, Violet, Sheep Sorrel, Blood Build, Red Clover, Yellow Dock, and Immunaid products were promoted with therapeutic claims, classifying them as unapproved new drugs under Section 201(g)(1)(B) and 201(p)(1) of the Act. These products are also misbranded under Section 502(f)(1) due to inadequate directions for lay use.

Specific CGMP violations included: * Failure to qualify suppliers by confirming the reliability of Certificates of Analysis (COAs) for components (21 CFR 111.75(a)(2)(ii)(A)). * Failure to establish specifications for manufacturing processes to ensure product quality (21 CFR 111.70(a)). * Failure to prepare complete written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(