FDA EIR - East West Tea Company, LLC - May 19, 2011

An FDA inspection of Golden Temple of Oregon, LLC's tea facility in Springfield, OR, took place from May 16-19, 2011. This comprehensive review, conducted under regulatory guidelines for dietary supplements and domestic food safety (CPGM 7321.008 and 7303.803), also followed up on earlier concerns regarding website health claims, which the company removed during the inspection. Investigators identified ten observations, largely focusing on critical omissions in the company's Master Manufacturing Records (MMRs) and Batch Production Records (BPRs). These violations included the absence of written specifications, representative labels, sampling procedures, and corrective action plans within MMRs. BPRs lacked documentation for equipment maintenance and cleaning, actual product labels, quality control (QC) review of test results, and final QC approval or rejection of packaged dietary supplements. Additionally, theoretical yield percentages were not recorded at appropriate production phases, and components were not adequately managed to prevent mix-ups, with one observation being a repeat issue. Management committed to correcting these deficiencies by enhancing MMRs/BPRs with detailed procedures for sampling, testing, corrective actions, equipment status, label references, and a robust quality control review and final release process, though specific timelines were not established.