FDA Inspection
Atrium Medical CorporationAtrium Medical Corporation – FDA Inspection, Sep 7, 2012
Record Details
This FDA Inspection record concerns Atrium Medical Corporation, with an inspection on September 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Atrium Medical Corporation
- Inspection Date
- September 7, 2012
- Product Type
- Devices
View Company Profile
ID · 050137f9-4270-4aad-a119-0fab87ef4166
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 799533
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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Other FDA inspections of Atrium Medical Corporation
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2026 | Not classified | New England District Office | Postmarket Assurance: Devices |
| November 26, 2024 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
| September 6, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 10, 2020 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 2, 2018 | OAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
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