Warning letter
Atrium Medical Corporation: warning letter of Oct 11, 2012
FDA warning letter 363780 · New England District Office
Key facts
| Reference number | 363780 |
|---|---|
| Company | Atrium Medical Corporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 11, 2012 |
| Posted date | Oct 11, 2012 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 820, 803 |
| Inspection city | Merrimack |
| Inspection ZIP | 03054 |
| Inspection start date | Jul 31, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: