Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
16 Dec 2008
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Juanita P Versace, Robert C Steyert, Dennis E Guilfoyle
16 Dec 2008
21 CFR 211.165(a)
Testing and release for distribution
Cited by Juanita P Versace, Robert C Steyert, Dennis E Guilfoyle
16 Dec 2008
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by Juanita P Versace, Robert C Steyert, Dennis E Guilfoyle
16 Dec 2008
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Juanita P Versace, Robert C Steyert, Dennis E Guilfoyle
16 Dec 2008
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Juanita P Versace, Robert C Steyert, Dennis E Guilfoyle
Inspected site
ARAmerican Regent, Inc.Shirley, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 310.305(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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