FDA-Inspected Site

New York Blood Center Enterprises

12 FDA inspections are on record for New York Blood Center Enterprises in Westbury, United States.

483· Form 483 issued

Westbury, United States · Last updated August 15, 2026

Overview

  • 12 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-07-08.

At a glance

Inspections

12

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Jul 2026 – 8 Jul 2026Biologics483View 483 →
10 Oct 2023 – 27 Oct 2023Biologics483View 483 →
6 Feb 2019 – 25 Feb 2019Biologics483View 483 →
7 Nov 2016 – 22 Nov 2016Biologics483On file
7 Oct 2013 – 29 Oct 2013Biologics483View 483 →
1 Nov 2011Not recorded483View 483 →
4 Sep 2009Not recorded483View 483 →
16 Jun 2008Not recordedClean
27 Sep 2007Not recordedClean
8 Sep 2005Not recordedClean
7 Jan 2004Not recordedClean
24 Oct 2000Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

8 Jul 2026
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Irina Gaberman

8 Jul 2026
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Irina Gaberman

8 Jul 2026
21 CFR 606.160(b)

Required records

Cited by Irina Gaberman

8 Jul 2026
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Irina Gaberman

27 Oct 2023
21 CFR 211.68(a)

Written calibration / inspection records not kept

Cited by Irina Gaberman

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations5x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations4x
21 CFR 606.160(b)Cited across public-safe Form 483 observations4x
21 CFR 606.100(c)Cited across public-safe Form 483 observations3x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations2x
21 CFR 600.14(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 606.60(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited across public-safe Form 483 observations1x
21 CFR 606.60(b)Cited across public-safe Form 483 observations1x
21 CFR 606.65(e)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind New York Blood Center Enterprises' 7 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