Overview
- 8 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.
18 Nov 2008
21 CFR 211.100(a)
Approval and review of procedures
Cited by Evelyn Taha, Sarah A Wangseng, Matthew R Palo
18 Nov 2008
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Evelyn Taha, Sarah A Wangseng, Matthew R Palo
18 Nov 2008
21 CFR 630.40(b)(1)
Deferred or not eligible
Cited by Evelyn Taha, Sarah A Wangseng, Matthew R Palo
18 Nov 2008
21 CFR 820.70(i)
Documentation of software validation
Cited by Evelyn Taha, Sarah A Wangseng, Matthew R Palo
Inspected site
TMThe Mount Sinai HospitalNew York, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
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