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Form 483

University of CA Irvine Medical Center Blood Bank Form 483, 2022-09-29

FDA issued a Form 483 to University of CA Irvine Medical Center Blood Bank on 2022-09-29 with 6 public-safe observations.

483· Form 483 issuedBiologics6 observations

University of CA Irvine Medical Center Blood Bank · Orange, United States · Issued September 29, 2022

Overview

  • 6 public-safe observations are available for this inspection.
  • 2 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.

29 Sep 2022
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Yvonne C Wilkes

29 Sep 2022
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Yvonne C Wilkes

29 Sep 2022
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Yvonne C Wilkes

29 Sep 2022
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Yvonne C Wilkes

29 Sep 2022
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Yvonne C Wilkes

Inspected site

UOUniversity of CA Irvine Medical Center Blood BankOrange, United States

Inspection team

YCYvonne C Wilkes

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations3x
21 CFR 606.60(a)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 6 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