Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-01.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Apr 2026 – 1 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Aug 2024 – 26 Nov 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Jul 2022 – 6 Sep 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Jan 2020 – 10 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jul 2018 – 2 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Dec 2015 – 8 Jan 2016 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Jun 2026
ISO 13485:2016 Clause 6.4.2
Requirements for contamination control of sterile devices not documented
Cited by Nabil Nakhoul
1 Jun 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Nabil Nakhoul
26 Nov 2024
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Justine M Corson, Diane M Biron
26 Nov 2024
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Justine M Corson, Diane M Biron
26 Nov 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Justine M Corson, Diane M Biron
Investigators
FDA investigators tied to this site in the record.
Justine M Corson2 insp.
Diane M Biron2 insp.
Nabil Nakhoul1 insp.
Maryam Tabatabaie1 insp.
Stephen C Smith1 insp.
Eric C Schmitt1 insp.
James W Whitney1 insp.
Christopher J Cruciotti1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Atrium Medical Corporation's 5 Form 483s
Source PDFs, verbatim observations, 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