Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-19.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Feb 2026 – 19 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Aug 2023 – 24 Aug 2023 | Medical Devices & Rad Health | Clean | |
| 29 Jun 2015 – 2 Jul 2015 | Medical Devices & Rad Health | WL | View 483 → |
| 17 Mar 2011 | Not recorded | 483 | On file |
| 17 Jun 2008 | Not recorded | Clean | |
| 30 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Feb 2026
ISO 13485:2016 Clause 7.4.1
Supplier monitoring and re-evaluation not planned
Cited by Christopher B May
19 Feb 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures not documented
Cited by Christopher B May
19 Feb 2026
ISO 13485:2016 Clause 8.3.1
Records of nonconforming product and actions taken not maintained
Cited by Christopher B May
Investigators
FDA investigators tied to this site in the record.
Christopher B May1 insp.
Alexandria L Capuano1 insp.
Lori J Silverstein1 insp.
Rodney D Combs1 insp.
Minh D Phan1 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 820.250(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | 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(d) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | 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 Prodimed's 3 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