Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-25.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Feb 2026 – 25 Feb 2026 | Medical Devices & Rad Health | Clean | |
| 26 Apr 2022 – 29 Apr 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Aug 2015 – 31 Aug 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Oct 2011 | Not recorded | Clean | |
| 8 Mar 2011 | Not recorded | WL | View 483 → |
| 16 May 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Apr 2022
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Javonica F Penn
31 Aug 2015
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Brigitte K Strelnik
31 Aug 2015
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Brigitte K Strelnik
8 Mar 2011
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Roy C Stephens, Christine E Kelley
8 Mar 2011
21 CFR 820.22
Quality Audits - defined intervals
Cited by Roy C Stephens, Christine E Kelley
Investigators
FDA investigators tied to this site in the record.
Amber M Capello-Jones1 insp.
Javonica F Penn1 insp.
Brigitte K Strelnik1 insp.
Elizabeth P Kinsella1 insp.
Roy C Stephens1 insp.
Christine E Kelley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DiaPharma Group Inc'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