Atlas

Form 483

Allendale IRB Form 483, 2011-02-23

FDA issued a Form 483 to Allendale IRB on 2011-02-23 with 3 public-safe observations.

483· Form 483 issued3 observations

Allendale IRB · Old Lyme, United States · Issued February 23, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

23 Feb 2011
21 CFR 56.109(f)

Continuing review

Cited by John S Hartford

23 Feb 2011
21 CFR 56.110(c)

Method to keep members advised

Cited by John S Hartford

23 Feb 2011
21 CFR 812.66

No IRB notification of significant risk determination

Cited by John S Hartford

Inspected site

AIAllendale IRBOld Lyme, United States

Inspection team

JSJohn S Hartford

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.109(f)Cited across public-safe Form 483 observations1x
21 CFR 56.110(c)Cited across public-safe Form 483 observations1x
21 CFR 812.66Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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