Atlas

Form 483

New York Blood Center, Inc. Form 483, 2026-07-17

FDA issued a Form 483 to New York Blood Center, Inc. on 2026-07-17 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

New York Blood Center, Inc. · New York, United States · Issued July 17, 2026

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Jul 2026
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Irina Gaberman

17 Jul 2026
21 CFR 606.100(b)

Written SOPs available for use by personnel

Cited by Irina Gaberman

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

Person performing, test results, interpretation

Cited by Irina Gaberman

Inspected site

NYNew York Blood Center, Inc.New York, United States

Inspection team

IGIrina Gaberman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations2x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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