Overview
- 6 public-safe observations are available for this inspection.
- 5 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.
20 Jun 2011
21 CFR 1271.200(b)
Procedures inadequate
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
20 Jun 2011
21 CFR 1271.210(a)
Use prior to verification
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
20 Jun 2011
21 CFR 1271.210(d)(2)
Verification elements
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
20 Jun 2011
21 CFR 1271.230(a)
Process validation procedures
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
20 Jun 2011
21 CFR 1271.230(a)
Validation & approval--established procedures
Cited by Leena Thomas, Susan T Hadman, Haydee B Romero
Inspected site
WMWestchester Medical Center Pathology DepartmentValhalla, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.210(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.210(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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