Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-18.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Dec 2025 – 18 Dec 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jan 2023 – 12 Jan 2023 | Medical Devices & Rad Health | Clean | |
| 17 Feb 2020 – 20 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Dec 2025
21 CFR 820.70(g)
Equipment Installation, Placement, Specified Requirements
Cited by Naakesh N Gomanie
18 Dec 2025
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
Cited by Naakesh N Gomanie
18 Dec 2025
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Naakesh N Gomanie
20 Feb 2020
21 CFR 820.120(b)
DHR documentation of label release {see also 820.184}
Cited by Gamal A Norton
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(b) | 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(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | 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 DiAgam Societe Anonyme (S.A.)'s 2 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