Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-11.
At a glance
Inspections
5
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Dec 2025 – 11 Dec 2025 | Medical Devices & Rad Health | Clean | |
| 23 May 2016 – 26 May 2016 | Medical Devices & Rad Health | Clean | |
| 20 Jan 2015 – 5 Feb 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jul 2013 – 22 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Jul 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2015
21 CFR 820.50(a)(1)
Evaluation and Selection, Suppliers, Contractors, etc.
Cited by Christine I Shaw
5 Feb 2015
21 CFR 820.70(b)
Production and Process Change Procedures, lack of or Inad.
Cited by Christine I Shaw
5 Feb 2015
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Christine I Shaw
Investigators
FDA investigators tied to this site in the record.
Christine I Shaw2 insp.
Alexandria L Capuano1 insp.
Daniel J Lahar1 insp.
Matthew M Vernon1 insp.
Lorna F Jones1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CEA Medical Manufacturing, Inc.'s 2 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