Overview
- 10 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-03-31.
At a glance
Inspections
10
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Mar 2023 – 31 Mar 2023 | Biologics | Clean | |
| 14 Dec 2017 – 15 Dec 2017 | Biologics | Clean | |
| 29 Jun 2016 – 8 Jul 2016 | Biologics | 483 | View 483 → |
| 21 Aug 2013 – 23 Aug 2013 | Biologics | Clean | |
| 28 Oct 2010 | Not recorded | Clean | |
| 3 Apr 2009 | Not recorded | Clean | |
| 2 Jul 2007 | Not recorded | Clean | |
| 4 Mar 2005 | Not recorded | Clean | |
| 12 Mar 2004 | Not recorded | Clean | |
| 9 Oct 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jul 2016
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Theressa B Smith, Julia D Cartwright
8 Jul 2016
21 CFR 606.100(c)
Record review prior to release
Cited by Theressa B Smith, Julia D Cartwright
8 Jul 2016
21 CFR 606.40(a)(1)
Provide space for examination
Cited by Theressa B Smith, Julia D Cartwright
8 Jul 2016
21 CFR 640.63(a)
Determination not made on day of collection
Cited by Theressa B Smith, Julia D Cartwright
Investigators
FDA investigators tied to this site in the record.
Lesley Mae P Lutao1 insp.
Marc A Jackson1 insp.
Theressa B Smith1 insp.
Julia D Cartwright1 insp.
Zerita White1 insp.
Albert F Peacock1 insp.
Darla J Christopher1 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 |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.63(a) | 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