FDA WARNING_LETTER - Sekisui Medical Co., Ltd - June 12, 2014

On October 17, 2014, the FDA issued a Warning Letter to Sekisui Medical Co. Ltd. following an inspection from June 9-12, 2014, in Ryugasaki-Shi, Japan. The inspection revealed that the firm's N-geneous LDL/HDL Cholesterol Calibrators and Reagents, and Lipase Color Reagent Solvent Activator and Calibrator, are adulterated under 21 U.S.C. § 351(h) because their manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)):** The firm's CAPA procedure (document (b)(4)) failed to identify all quality data sources for analysis and lacked instructions for identifying causes of nonconforming products or quality problems. The firm's July 3, 2014, response was inadequate, as it did not provide evidence of revised procedures including quality data sources, retrospective data review, or employee training. 2. **Inadequate process validation (21 CFR 820.75(a)):** The (b)(4) for Cholesterol LDL-C Calibrator manufacturing was not validated. The firm's