Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-04-04.
At a glance
Inspections
9
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Mar 2025 – 4 Apr 2025 | Human Drugs | 483 | View 483 → |
| 15 Oct 2024 – 17 Oct 2024 | Human Drugs | Clean | |
| 9 Dec 2019 – 13 Dec 2019 | Human Drugs | Clean | |
| 5 Jan 2015 – 9 Jan 2015 | Human Drugs | Clean | |
| 22 Oct 2012 | Not recorded | Clean | |
| 3 Mar 2011 | Not recorded | Clean | |
| 17 Feb 2006 | Not recorded | Clean | |
| 19 Aug 2003 | Not recorded | Clean | |
| 8 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Apr 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Gretchen M Laws, Michael Z Weigman
4 Apr 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Gretchen M Laws, Michael Z Weigman
4 Apr 2025
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by Gretchen M Laws, Michael Z Weigman
Investigators
FDA investigators tied to this site in the record.
Marie F Morin2 insp.
Gretchen M Laws1 insp.
Michael Z Weigman1 insp.
Ann B Borromeo1 insp.
Susan O Oladeji1 insp.
Marvin D Jones1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind USAntibiotics LLC's 1 Form 483
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