Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-09.
At a glance
Inspections
10
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Dec 2022 – 9 Dec 2022 | Animal Drugs & Feeds | Clean | |
| 2 Mar 2020 – 19 Mar 2020 | Animal Drugs & Feeds | 483 | View 483 → |
| 8 Aug 2016 – 19 Aug 2016 | Animal Drugs & Feeds | 483 | View 483 → |
| 4 Sep 2009 | Not recorded | 483 | On file |
| 15 Dec 2006 | Not recorded | Clean | |
| 9 Apr 2004 | Not recorded | Clean | |
| 25 Jun 2002 | Not recorded | Clean | |
| 17 May 2002 | Not recorded | Clean | |
| 21 Apr 2000 | Not recorded | Clean | |
| 24 Nov 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Mar 2020
21 CFR 58.107
Test article: handling
Cited by Hugh M Mcclure, Theressa B Smith, Stefanie R Cook, Joo Jin
19 Mar 2020
21 CFR 58.120(a)
Protocol: approved
Cited by Hugh M Mcclure, Theressa B Smith, Stefanie R Cook, Joo Jin
19 Mar 2020
21 CFR 58.130(a)
Conduct: in accordance with protocol
Cited by Hugh M Mcclure, Theressa B Smith, Stefanie R Cook, Joo Jin
19 Mar 2020
21 CFR 58.185(a)(13)
Final report: storage locations
Cited by Hugh M Mcclure, Theressa B Smith, Stefanie R Cook, Joo Jin
19 Mar 2020
21 CFR 58.185(a)(9)
Final report: circumstances affecting data qual., integrity
Cited by Hugh M Mcclure, Theressa B Smith, Stefanie R Cook, Joo Jin
Investigators
FDA investigators tied to this site in the record.
Stefanie R Cook2 insp.
Theressa B Smith2 insp.
Ruth A Williams1 insp.
Hugh M Mcclure1 insp.
Joo Jin1 insp.
Stephen T Hansen1 insp.
Hanna L Potter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.130(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.185(a)(13) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.31(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.33(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.63(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.90(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.90(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.107 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.190(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.190(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.195(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.51 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.61 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.63(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Southwest Bio-Labs, Inc.'s 3 Form 483s
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