Overview
- 3 public-safe observations are available for this inspection.
- 3 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 Nov 2013
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Michele L Obert, Victoria A Wagoner
1 Nov 2013
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Michele L Obert, Victoria A Wagoner
1 Nov 2013
21 CFR 211.194(a)
Complete test data included in records
Cited by Michele L Obert, Victoria A Wagoner
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 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 observations
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