Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-04-04.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Mar 2023 – 4 Apr 2023 | Biologics | 483 | View 483 → |
| 27 Apr 2017 – 28 Apr 2017 | Biologics | Clean | |
| 30 Jun 2014 – 1 Jul 2014 | Biologics | Clean | |
| 21 Dec 2011 | Not recorded | Clean | |
| 24 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Erika M Wilkerson1 insp.
Herbert M Corbello1 insp.
Francis A Guidry1 insp.
Charles N Dupont1 insp.
Brian S Lynch1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.40(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biomat USA Inc's 1 Form 483
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