Overview
- 13 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-08.
At a glance
Inspections
13
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2026 – 8 Jun 2026 | Biologics | Clean | |
| 25 Jun 2024 – 2 Jul 2024 | Biologics | 483 | View 483 → |
| 8 Apr 2022 – 13 Apr 2022 | Biologics | Clean | |
| 18 Jan 2018 – 24 Jan 2018 | Biologics | Clean | |
| 18 Nov 2015 – 19 Nov 2015 | Biologics | Clean | |
| 24 Jul 2014 – 28 Jul 2014 | Biologics | Clean | |
| 6 Jan 2012 | Not recorded | Clean | |
| 17 Aug 2010 | Not recorded | 483 | View 483 → |
| 18 Nov 2008 | Not recorded | 483 | View 483 → |
| 20 Jun 2007 | Not recorded | Clean | |
| 12 Aug 2005 | Not recorded | Clean | |
| 23 Sep 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Aug 2010
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Irina Gaberman, Matthew R Palo
17 Aug 2010
21 CFR 606.100(b)(2)
Donor qualifying tests & measurements
Cited by Irina Gaberman, Matthew R Palo
Investigators
FDA investigators tied to this site in the record.
Evelyn Taha3 insp.
Irina Gaberman2 insp.
Amy W Yan Mai2 insp.
Matthew R Palo2 insp.
Amy Kim1 insp.
Amy W Yan-Mai1 insp.
Jennifer L Custodio1 insp.
Sarah A Wangseng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 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 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(21) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.4(h) | 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 site report
Get the verbatim findings behind The Mount Sinai Hospital's 3 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat