# FDA WARNING_LETTER - Shima Laboratories Co., Ltd. - October 03, 2013

Source: https://www.keypedia.com/records/warning_letter/shima-laboratories-co-ltd/f0cec3c2-9f54-4478-8824-ba07b706c4c6

> FDA WARNING_LETTER for Shima Laboratories Co., Ltd. on October 03, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Shima Laboratories Co., Ltd.
- Inspection Date: 2013-10-03
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)

Company: https://www.keypedia.com/companies/shima-laboratories-co-ltd/1feba4aa-73ed-404c-8959-ed254ec8f8c4

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7