Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-25.
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 |
|---|---|---|---|
| 31 Jul 2023 – 25 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Dec 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Aug 2023
21 CFR 812.100
Investigator lack of informed consent
Cited by Corrine M Carter, Jennifer A Kemp
25 Aug 2023
21 CFR 812.100
Investigator non-compliance with agreement/plan/regulations
Cited by Corrine M Carter, Jennifer A Kemp
25 Aug 2023
21 CFR 812.140(a)(1)
Investigator correspondence records inadequate
Cited by Corrine M Carter, Jennifer A Kemp
25 Aug 2023
21 CFR 812.140(a)(3)(ii)
Investigator records of relevant observations inadequate
Cited by Corrine M Carter, Jennifer A Kemp
25 Aug 2023
21 CFR 812.140(a)(4)
Investigator record of protocol deviations inadequate
Cited by Corrine M Carter, Jennifer A Kemp
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 812.100 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.140(a)(3)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 50.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.150(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.36(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Miguelangelo J. Perez-Cruet, M.D., M.S.'s 2 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