Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
21 Apr 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
21 Apr 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
21 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
21 Apr 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
21 Apr 2026
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 observations
The full inspection record, as Atlas holds it, 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