Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-06-09.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jun 2022 – 9 Jun 2022 | Biologics | Clean | |
| 9 Jul 2018 – 13 Jul 2018 | Biologics | 483 | View 483 → |
| 24 Jun 2014 – 26 Jun 2014 | Biologics | Clean | |
| 25 Oct 2011 | Not recorded | Clean | |
| 11 Dec 2009 | Not recorded | Clean | |
| 7 Jan 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jul 2018
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Nancy L Neiger
Investigators
FDA investigators tied to this site in the record.
Nancy L Neiger2 insp.
Nisha C Patel1 insp.
Laressa R Gray1 insp.
Thomas W Nojek1 insp.
Jennifer L Jager1 insp.
Andria L Kuhlman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biomat USA Inc.'s 1 Form 483
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