Form 483

University of Texas MD Anderson Cancer Center Form 483, 2022-03-24

FDA issued a Form 483 to University of Texas MD Anderson Cancer Center on 2022-03-24 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

University of Texas MD Anderson Cancer Center · Houston, United States · Issued March 24, 2022

Overview

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

Inspectional observations

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

24 Mar 2022
21 CFR 211.115(a)

Reprocessing procedures not written or followed

Cited by Darla J Christopher, Lauren M Lilly

24 Mar 2022
21 CFR 211.115(a)

Reprocessing procedures not written or followed

Cited by Darla J Christopher, Lauren M Lilly

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.115(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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