Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-07-13.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 May 2016 – 13 Jul 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jul 2013 – 1 Oct 2013 | Medical Devices & Rad Health | 483 | On file |
| 7 Sep 2012 | Not recorded | WL | On file |
| 15 Mar 2010 | Not recorded | Clean | |
| 20 Nov 2009 | Not recorded | 483 | On file |
| 8 May 2008 | Not recorded | Clean | |
| 17 Aug 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Tamara S Rosbury2 insp.
Stephen C Smith2 insp.
Maura Rooney1 insp.
Megan A Haggerty1 insp.
Abby E Pelletier1 insp.
George T Allen1 insp.
Stephen C King1 insp.
Jonathan B Lewis1 insp.
Philip H Lafleur1 insp.
Todd J Maushart1 insp.
David P Vanhouten1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Atrium Medical Corporation's 4 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat