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Form 483

RWJ Barnabas Health-Newark Beth Israel Medical Center - Blood Bank Form 483, 2023-10-13

FDA issued a Form 483 to RWJ Barnabas Health-Newark Beth Israel Medical Center - Blood Bank on 2023-10-13 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

RWJ Barnabas Health-Newark Beth Israel Medical Center - Blood Bank · Newark, United States · Issued October 13, 2023

Overview

  • 2 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.

13 Oct 2023
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Amy W Yan-Mai

13 Oct 2023
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Amy W Yan-Mai

Inspected site

RBRWJ Barnabas Health-Newark Beth Israel Medical Center - Blood BankNewark, United States

Inspection team

AWAmy W Yan-Mai

Cited regulations

CFR citations associated with this Form 483.

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

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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