Atlas

Form 483

Banner - University Medical Center Tuscon Form 483, 2016-07-28

FDA issued a Form 483 to Banner - University Medical Center Tuscon on 2016-07-28 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Banner - University Medical Center Tuscon · Tucson, United States · Issued July 28, 2016

Overview

  • 2 public-safe observations are 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.

28 Jul 2016
21 CFR 1271.160(a)

All core requirements covered in program

Cited by Travis R Hunt

28 Jul 2016
21 CFR 1271.160(a)

All core requirements covered in program

Cited by Travis R Hunt

Inspected site

B-Banner - University Medical Center TusconTucson, United States

Inspection team

TRTravis R Hunt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.160(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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