FDA Inspection
Atrium Medical CorporationAtrium Medical Corporation – FDA Inspection, Aug 2, 2018
Record Details
This FDA Inspection record concerns Atrium Medical Corporation, with an inspection on August 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 1de30126-bae7-433b-a9eb-7665407996ba
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1060821
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.72(b)Remedial action
- 21 CFR 820.75(a)Lack of or inadequate process validation
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 |
| 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 |
| July 13, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Atrium Medical Corporation
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.