Golden Temple of Oregon, LLC - Tea Facility – FDA Warning Letter, May 19, 2011

On May 16-19, 2011, the FDA inspected East West Tea Company (formerly Golden Temple of Oregon, LLC) in Springfield, Oregon, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their products adulterated.

Key violations included: 1. **Master Manufacturing Records (MMR) Deficiencies:** MMRs for all products, including "Egyptian Licorice INT" and "Egyptian Licorice 6-Pack," lacked required information such as specifications for manufacturing control points, sampling procedures, cross-references to test procedures, and corrective action plans (21 CFR 111.210(h)). The MMRs also did not include a representative label or a cross-reference to its physical location (21 CFR 111.210(g)). 2. **Batch Production Record Deficiencies:** Batch production records for products like "Egyptian Licorice 6-Pack" and "Egyptian Licorice INT" lacked documentation of quality control personnel review of test results (21 CFR 111.260(1)(1)(ii)) and a statement of percentage of theoretical yield at appropriate processing phases (21 CFR 111.260(f)). 3. **Component Handling:** The firm failed to hold components under conditions to avoid mix-ups, with unlabelled