Overview
- 22 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-03.
At a glance
Inspections
22
Form 483s
12
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 3 Apr 2026 | Biologics | 483 | View 483 → |
| 16 Sep 2025 – 24 Sep 2025 | Biologics | 483 | View 483 → |
| 5 Sep 2023 – 7 Sep 2023 | Biologics | Clean | |
| 4 Feb 2020 – 11 Feb 2020 | Biologics | 483 | View 483 → |
| 8 Nov 2017 – 22 Nov 2017 | Biologics | 483 | On file |
| 6 Sep 2017 – 29 Sep 2017 | Biologics | 483 | View 483 → |
| 6 Oct 2015 – 22 Oct 2015 | Biologics | 483 | On file |
| 14 Sep 2015 – 30 Sep 2015 | Biologics | 483 | View 483 → |
| 28 Mar 2013 – 7 May 2013 | Biologics | 483 | View 483 → |
| 19 Mar 2013 – 8 Apr 2013 | Biologics | 483 | On file |
| 15 Nov 2012 | Not recorded | Clean | |
| 2 Aug 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Apr 2026
21 CFR 600.15
Blood & Blood Components
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
3 Apr 2026
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
3 Apr 2026
21 CFR 606.160(a)(1)
Concurrent documentation
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
3 Apr 2026
21 CFR 606.160(b)
Required records
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
3 Apr 2026
21 CFR 606.171
Biological product deviation report
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
Investigators
FDA investigators tied to this site in the record.
Irina Gaberman7 insp.
Evelyn Taha5 insp.
Jacqueline M Diaz Albert3 insp.
Emily A Walters1 insp.
Jennifer L Diaz1 insp.
Burnell M Henry1 insp.
Mercy O Quagraine1 insp.
Gene D Arcy1 insp.
Leena Thomas1 insp.
Matthew R Palo1 insp.
Gang Wang1 insp.
Mohammad A Heidaran1 insp.
Amy W Yan Mai1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 600.15 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.12(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(15) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.140(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.140(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.15(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind New York Blood Center Enterprises' 12 Form 483s
Source PDFs, 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