FDA WARNING_LETTER - SUZUKEN CO., LTD. OGUCHI CENTER - January 30, 2014

On January 27-30, 2014, an FDA inspection of SUZUKEN CO., LTD. in Japan, a manufacturer of Holter ECG monitoring devices and electrodes, found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Key violations, many repeat observations from a previous inspection, include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: Seven CAPAs from October 2012-October 2013 lacked corrective actions. The firm's response to review and complete CAPAs and conduct training was deemed inadequate without evidence of completion. 2. **Failure to maintain complaint files and procedures (21 CFR 820.198(a))**: The complaint handling procedure did not ensure RMA email requests were reviewed for complaint documentation. Emails alleging device failure for specific RMAs were not uniformly or timely documented as complaints. The firm's response to include repair work in complaint data and implement a database was inadequate as it did not address revising procedures or retrospectively evaluating past RMA emails. 3. **Failure to investigate complaints (21 CFR 820.198(c))**: Specific complaints were not investigated because devices were