Atlas

Form 483

Newark Beth Israel Med Ctr IRB Form 483, 2013-11-05

FDA issued a Form 483 to Newark Beth Israel Med Ctr IRB on 2013-11-05 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Newark Beth Israel Med Ctr IRB · Newark, United States · Issued November 5, 2013

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.

5 Nov 2013
21 CFR 56.108(a)(1)

Initial and continuing reviews

Cited by Krystal O Ogunremi

5 Nov 2013
21 CFR 56.108(b)(2)

Prompt reporting of noncompliance

Cited by Krystal O Ogunremi

Inspected site

NBNewark Beth Israel Med Ctr IRBNewark, United States

Inspection team

KOKrystal O Ogunremi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.108(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 56.108(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, 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