FDA WARNING_LETTER - Atom Medical Corporation - September 20, 2013

On March 28, 2014, the FDA issued a Warning Letter to Atom Medical Corporation following an inspection from September 17-20, 2013, in Saitama City, Japan. The inspection revealed that the firm's infant incubators, warmers, transport incubators, infusion pumps, infant resuscitation units, and gynecological/obstetrics equipment are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(3)):** The firm did not take preventive actions for recurring serious issues like electrical current leakage in Dual Incu I incubators, and failed to perform retrospective reviews or provide adequate employee training. 2. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)):** Complaint procedures (AS-1402) and forms did not ensure evaluation for Medical Device Reporting (MDR) reportability (21 CFR Part 803). Retrospective review and employee training were also inadequate. 3. **Failure to evaluate and select suppliers (21 CFR 820.50(a)(1)):** The firm