FDA WARNING_LETTER - Meridian Co., Ltd. - May 29, 2014

On August 19, 2014, the FDA issued a Warning Letter to Meridian Co., Ltd. following an inspection from May 26-29, 2014, which found their infrared lamps and plethysmographs to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's June 12, 2014 response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to classify product malfunctions as complaints, evaluate for MDR reportability, and provide documentation of revised procedures and training. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** CAPA procedure lacked verification/validation requirements, and nonconformance reports were not analyzed for root causes. Response lacked implementation documentation. 3. **Purchasing Controls (21 CFR 820.50):** Exempted components from supplier qualification without specification, lacked contracts with major suppliers, and failed to maintain records of acceptable suppliers. No corrective action description provided. 4. **Equipment Calibration (21 CFR 820.72(