Atlas

Form 483

NewYork-Presbyterian Columbia Irving Medical Center Form 483, 2009-04-09

FDA issued a Form 483 to NewYork-Presbyterian Columbia Irving Medical Center on 2009-04-09 with 3 public-safe observations.

483· Form 483 issued3 observations

NewYork-Presbyterian Columbia Irving Medical Center · New York, United States · Issued April 9, 2009

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.

9 Apr 2009
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Evelyn Taha

9 Apr 2009
21 CFR 606.40

Clean & orderly

Cited by Evelyn Taha

9 Apr 2009
21 CFR 820.75(a)

Documentation

Cited by Evelyn Taha

Inspected site

NCNewYork-Presbyterian Columbia Irving Medical CenterNew York, United States

Inspection team

ETEvelyn Taha

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.40Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)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