Atlas

Form 483

Hoxworth Blood Center University of Cincinnati Form 483, 2013-01-07

FDA issued a Form 483 to Hoxworth Blood Center University of Cincinnati on 2013-01-07 with 3 public-safe observations.

483· Form 483 issued3 observations

Hoxworth Blood Center University of Cincinnati · Fort Mitchell, United States · Issued January 7, 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.

7 Jan 2013
21 CFR 606.40(a)(1)

Provide space for examination

Cited by Jennifer L Jager

7 Jan 2013
21 CFR 606.160(a)(2)

Determination of lot numbers and supplies

Cited by Jennifer L Jager

7 Jan 2013
21 CFR 640.4(f)

Arm preparation

Cited by Jennifer L Jager

Inspected site

HBHoxworth Blood Center University of CincinnatiFort Mitchell, United States

Inspection team

JLJennifer L Jager

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.160(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 606.40(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 640.4(f)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