Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-01.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2024 – 1 Apr 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Oct 2015 – 4 Nov 2015 | Medical Devices & Rad Health | Clean | |
| 5 Nov 2013 – 13 Nov 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Dec 2012 | Not recorded | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Apr 2024
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Felicia E Hinojosa, Felicia E Armbrustmacher
Investigators
FDA investigators tied to this site in the record.
Thomas A Peter2 insp.
Felicia E Hinojosa1 insp.
Felicia E Armbrustmacher1 insp.
Deanna L Lampley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Excel Medical Products, Inc.'s 3 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