Overview
- 6 public-safe observations are available for this inspection.
- 2 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.
1 Aug 2019
21 CFR 211.42(c)(10)(i)
Floors, walls, ceiling surfaces
Cited by Marcus F Yambot, Alan L Truong
1 Aug 2019
21 CFR 211.42(c)(10)(i)
Floors, walls, ceiling surfaces
Cited by Marcus F Yambot, Alan L Truong
1 Aug 2019
21 CFR 211.42(c)(10)(i)
Floors, walls, ceiling surfaces
Cited by Marcus F Yambot, Alan L Truong
1 Aug 2019
21 CFR 211.87
Retest of approved components/containers/closures
Cited by Marcus F Yambot, Alan L Truong
1 Aug 2019
21 CFR 211.87
Retest of approved components/containers/closures
Cited by Marcus F Yambot, Alan L Truong
Inspected site
AUArgenta US Manufacturing LLCShawnee, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 3x |
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 6 observations
The source PDF and every observation in full, 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