Company
United StatesAtrium Medical Corporation, Merrimack, NH – FDA Inspections
Inspection records and compliance data for Atrium Medical Corporation in Merrimack, New Hampshire. 11 FDA inspections on record (5 OAI), 3 Form 483s, 1 warning letter, last inspected June 01, 2026.
Company Profile
This profile covers Atrium Medical Corporation based in Merrimack, New Hampshire, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 5
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 1
First inspected November 20, 2009. Last inspected June 1, 2026.
Most cited issue areas
- Environmental control Lack of or inadequate procedures3 inspections
- Lack of or inadequate procedures3 inspections
- Lack of or inadequate process validation3 inspections
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 1, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1322014 |
| November 26, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1232907 |
| September 6, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1178933 |
| February 10, 2020 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1117399 |
| August 2, 2018 | OAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1060821 |
| July 13, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 977679 |
| January 8, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 956620 |
| October 1, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 840237 |
| September 7, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 799533 |
| March 15, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 651907 |
| November 20, 2009 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 630366 |
FDA documents
Form 483s (4)
- Form 483s · November 26, 2024
- Form 483s · September 6, 2022
- Form 483s · February 10, 2020
- Form 483s · August 2, 2018
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Atrium Medical Corporation
FEI Number
3011175548
Address
40 Continental Blvd, Merrimack, New Hampshire 03054, United States
Country
United States
ID: a210e43f-6ec7-4e83-83ee-1650b1cedd35