Overview
- 12 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-06.
At a glance
Inspections
12
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2025 – 6 Feb 2025 | Biologics | Clean | |
| 22 Jul 2019 – 24 Jul 2019 | Biologics | Clean | |
| 13 Oct 2016 – 14 Oct 2016 | Biologics | Clean | |
| 3 Nov 2015 – 6 Nov 2015 | Biologics | Clean | |
| 30 Oct 2013 – 1 Nov 2013 | Biologics | 483 | View 483 → |
| 26 Apr 2012 | Not recorded | Clean | |
| 4 Jun 2010 | Not recorded | Clean | |
| 8 Aug 2008 | Not recorded | 483 | On file |
| 21 Mar 2003 | Not recorded | Clean | |
| 23 Jan 2002 | Not recorded | Clean | |
| 18 May 2001 | Not recorded | Clean | |
| 28 Sep 2000 | 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.
Kathryn A Krentz2 insp.
Mark W Babbitt2 insp.
Paul M Chefor1 insp.
Barbara T Carmichael1 insp.
Donald W Jehn1 insp.
Alexander M Kay1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 630.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.66 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biomat USA, Inc.'s 2 Form 483s
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