Atlas

Form 483

Forest Research Institute, Inc. Form 483, 2013-02-21

FDA issued a Form 483 to Forest Research Institute, Inc. on 2013-02-21 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Forest Research Institute, Inc. · Jersey City, United States · Issued February 21, 2013

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.

21 Feb 2013
21 CFR 312.50

Ensuring compliance with plan and protocol

Cited by Christina N Maurino

21 Feb 2013
21 CFR 312.50

General responsibilities of sponsors

Cited by Christina N Maurino

21 Feb 2013
21 CFR 312.53(c)(4)

Financial information - sufficient and accurate

Cited by Christina N Maurino

Inspected site

FRForest Research Institute, Inc.Jersey City, United States

Inspection team

CNChristina N Maurino

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations2x
21 CFR 312.53(c)(4)Cited 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