Atlas

Form 483

Cleveland Clinic Form 483, 2013-04-03

FDA issued a Form 483 to Cleveland Clinic on 2013-04-03 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Cleveland Clinic · Cleveland, United States · Issued April 3, 2013

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

3 Apr 2013
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Nancy L Neiger

Inspected site

CCCleveland ClinicCleveland, United States

Inspection team

NLNancy L Neiger

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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