Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
23 Jul 2021
21 CFR 58.120(b)
Protocol: approval of changes
Cited by Nicole C Victoria, Eric S Myskowski
23 Jul 2021
21 CFR 58.185(a)(13)
Final report: storage locations
Cited by Nicole C Victoria, Eric S Myskowski
23 Jul 2021
21 CFR 58.31(e)
Management: availability of resources
Cited by Nicole C Victoria, Eric S Myskowski
23 Jul 2021
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Nicole C Victoria, Eric S Myskowski
23 Jul 2021
21 CFR 58.33(f)
Study director: transfer of data to archives
Cited by Nicole C Victoria, Eric S Myskowski
Inspected site
GLGeneva Laboratories, IncElkhorn, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(e) | 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(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.61 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.63(a) | 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 9 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