Atlas

Form 483

University Of Texas MD Anderson Cancer Center: PET Form 483, 2013-09-16

FDA issued a Form 483 to University Of Texas MD Anderson Cancer Center: PET on 2013-09-16 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

University Of Texas MD Anderson Cancer Center: PET · Houston, United States · Issued September 16, 2013

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.

16 Sep 2013
21 CFR 212.30(b)

Equipment not clean

Cited by Stephen D Brown

16 Sep 2013
21 CFR 212.50(a)

Written control procedures

Cited by Stephen D Brown

16 Sep 2013
21 CFR 212.71(a)

Non-Conforming Product Investigation Incomplete

Cited by Stephen D Brown

Inspected site

UOUniversity Of Texas MD Anderson Cancer Center: PETHouston, United States

Inspection team

SDStephen D Brown

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.30(b)Cited across public-safe Form 483 observations1x
21 CFR 212.50(a)Cited across public-safe Form 483 observations1x
21 CFR 212.71(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