Atlas

Form 483

Center For Organ Recovery & Education Form 483, 2015-08-26

FDA issued a Form 483 to Center For Organ Recovery & Education on 2015-08-26 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Center For Organ Recovery & Education · Pittsburgh, United States · Issued August 26, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

26 Aug 2015
21 CFR 1271.200(b)

Procedures inadequate

Cited by Travis R Hunt, Brandon M Kurjanowicz

26 Aug 2015
21 CFR 1271.320(a)

Procedures re complaints

Cited by Travis R Hunt, Brandon M Kurjanowicz

Inspected site

CFCenter For Organ Recovery & EducationPittsburgh, United States

Inspection team

TRTravis R Hunt
BMBrandon M Kurjanowicz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.200(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.320(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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