Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-28.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 May 2026 – 28 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Oct 2023 – 19 Oct 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jul 2017 – 27 Jul 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 May 2013 – 17 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 May 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures lack required elements
Cited by Shannon A Gregory
19 Oct 2023
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
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 1040.10(h)(2)(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1002.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | 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 |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lambda SpA's 4 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