FDA Inspection
Atom Medical CorporationAtom Medical Corporation – FDA Inspection, Sep 20, 2013
Record Details
This FDA Inspection record concerns Atom Medical Corporation, with an inspection on September 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Atom Medical Corporation
- Inspection Date
- September 20, 2013
- Product Type
- Devices
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ID · bff8ba74-ab8c-4d24-a261-3d1064563c93
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 851256
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Atom Medical Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Atom Medical Corporation
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