Atlas

Form 483

The Feinstein Institute for Medical Research Form 483, 2018-01-25

FDA issued a Form 483 to The Feinstein Institute for Medical Research on 2018-01-25 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

The Feinstein Institute for Medical Research · Manhasset, United States · Issued January 25, 2018

Overview

  • 4 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.

25 Jan 2018
21 CFR 212.60(d)

Supplies adequately controlled

Cited by Mindy M Chou

25 Jan 2018
21 CFR 212.60(e)

Equipment

Cited by Mindy M Chou

25 Jan 2018
21 CFR 212.60(g)(3)

Record of all test data

Cited by Mindy M Chou

25 Jan 2018
21 CFR 212.60(g)(3)

Complete record of all laboratory test data

Cited by Mindy M Chou

Inspected site

TFThe Feinstein Institute for Medical ResearchManhasset, United States

Inspection team

MMMindy M Chou

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.60(g)(3)Cited across public-safe Form 483 observations2x
21 CFR 212.60(d)Cited across public-safe Form 483 observations1x
21 CFR 212.60(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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