Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
19 Jan 2016
21 CFR 212.20(d)
Determination need for investigation
Cited by Vioela J Caze, Kenneth H Williams, Robert C Steyert
19 Jan 2016
21 CFR 212.20(d)
Determination need for investigation
Cited by Vioela J Caze, Kenneth H Williams, Robert C Steyert
19 Jan 2016
21 CFR 212.70(a)
Specifications
Cited by Vioela J Caze, Kenneth H Williams, Robert C Steyert
19 Jan 2016
21 CFR 212.70(a)
Specifications
Cited by Vioela J Caze, Kenneth H Williams, Robert C Steyert
19 Jan 2016
21 CFR 212.70(f)(1)(vi)
Documenting conditional release
Cited by Vioela J Caze, Kenneth H Williams, Robert C Steyert
Inspected site
TFThe Feinstein Institute for Medical ResearchManhasset, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.70(f)(1)(vi) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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