# FDA WARNING_LETTER - Atom Medical Corporation - September 20, 2013

Source: https://www.keypedia.com/records/warning_letter/atom-medical-corporation/39ba6293-d8e4-47aa-a2c9-832d6603ae7c

> FDA WARNING_LETTER for Atom Medical Corporation on September 20, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Atom Medical Corporation
- Inspection Date: 2013-09-20
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Owner & Operator](https://www.keypedia.com/people/rene-van-de-zande/34d54c16-0fc0-4821-9658-4d31ec4d6ca1)
- [Tsuyoshi Sugino](https://www.keypedia.com/people/tsuyoshi-sugino/f4c8ba2b-11b6-4d5f-bc23-c83904a5ec11)

Company: https://www.keypedia.com/companies/atom-medical-corporation/70f3b100-704e-4eec-865d-dadce2d44d1e

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