Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-07.
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 |
|---|---|---|---|
| 29 Aug 2022 – 7 Sep 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Aug 2013 – 12 Sep 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jun 2012 | Not recorded | 483 | View 483 → |
| 22 Nov 2011 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Sep 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Benjamin J Dastoli
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 820.30(g) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | 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 |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lucero Medical LLC'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