# FDA WARNING_LETTER - Asahi Kasai Medical Co., Ltd. - March 14, 2013

Source: https://www.keypedia.com/records/warning_letter/asahi-kasai-medical-co-ltd/687d0b60-87d5-4206-9b97-af8d2e3b2a20

> FDA WARNING_LETTER for Asahi Kasai Medical Co., Ltd. on March 14, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Asahi Kasai Medical Co., Ltd.
- Inspection Date: 2013-03-14
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On March 11-14, 2013, an FDA inspection of Asahi Kasei Medical Co. Ltd. in Oita-shi, Japan, revealed violations concerning their dialyzers, plasmapheresis, and leukocyte reduction filters. The firm's devices were deemed misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required material or information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include:
1.  **Failure to timely report MDRs (21 CFR 803.50(a)(1))**: Numerous events reasonably suggesting a device caused or contributed to death or serious injury were not reported within 30 calendar days. Examples provided show delays of over a year for some reports.
2.  **Inadequate MDR procedures (21 CFR 803.17)**: The firm's procedure (SOP-4TAQ-81001, Rev. 2.0) lacked definitions for reportable events, instructions for completing and submitting FDA 3500A forms, circumstances for initial/supplemental/follow-up reports, and proper documentation/record-keeping requirements for adverse event information and decision-making processes.

Additionally, the inspection identified Quality

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Shinya Eguchi](https://www.keypedia.com/people/shinya-eguchi/6f41819c-87a9-4f1e-baff-b640ec79d2a1)
- [Yoshitada Itoh](https://www.keypedia.com/people/yoshitada-itoh/dc924d4b-6664-41b1-81f8-9d6163ebb988)

Company: https://www.keypedia.com/companies/asahi-kasai-medical-co-ltd/3542e224-8e94-46ea-8fbc-c40907eb2dd9

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