FDA Inspection
Atrium Medical CorporationAtrium Medical Corporation – FDA Inspection, Nov 26, 2024
Record Details
This FDA Inspection record concerns Atrium Medical Corporation, with an inspection on November 26, 2024, issued by the New England District Office, covering medical devices & rad health.
- Company
- Atrium Medical Corporation
- Inspection Date
- November 26, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 0f96b290-a02c-4cf2-94e4-7d727b0d53e2
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1232907
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued, view the record
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| July 13, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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