Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-26.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 May 2026 – 26 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Nov 2024 – 15 Nov 2024 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2026
21 CFR 820.35(a)
Records of complaint investigations do not include required information
Cited by Felix J Marrero
26 May 2026
ISO 13485:2016 Clause 6.1(b)
Resources for meeting regulatory and customer requirements not provided
Cited by Felix J Marrero
26 May 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures lack required elements
Cited by Felix J Marrero
15 Nov 2024
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Felix J Marrero
Investigators
FDA investigators tied to this site in the record.
Felix J Marrero2 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.35(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.1(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MEDICA S.p.A. Socio Unico'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