Overview
- 15 public-safe observations are available for this inspection.
- 15 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
SBSouthwest Bio-Labs, Inc.Las Cruces, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 58.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(6) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(g) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 15 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere