Shima Laboratories Co., Ltd. – FDA Warning Letter, Oct 3, 2013

On March 21, 2014, the FDA issued a Warning Letter to SHIMA Laboratories Co., Ltd. following an inspection from September 30 to October 3, 2013. The inspection found that the firm's K-Assay D-Dimer and K-Assay D-Dimer Calibrator devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's response dated October 24, 2013, was deemed inadequate.

Key violations included: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1))**: The K-Assay D-Dimer products were not subjected to design control, and the firm failed to provide documentation of staff training on revised SOPs or a comprehensive retrospective assessment. 2. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(1))**: The firm had not identified quality data sources for analysis to detect recurring problems, lacking staff training documentation and a retrospective assessment. 3. **Failure to validate processes (21 CFR 820.75(a))**: A manufacturing process for the D-Dimer Assay