Asahi Kasai Medical Co., Ltd. – FDA Warning Letter, Mar 14, 2013

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