Atlas

Form 483

West Virginia University Hospitals, Inc. Form 483, 2013-04-04

FDA issued a Form 483 to West Virginia University Hospitals, Inc. on 2013-04-04 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

West Virginia University Hospitals, Inc. · Morgantown, United States · Issued April 4, 2013

Overview

  • 2 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.

4 Apr 2013
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Paula J Bretz

4 Apr 2013
21 CFR 606.100(c)

Thorough investigations

Cited by Paula J Bretz

Inspected site

WVWest Virginia University Hospitals, Inc.Morgantown, United States

Inspection team

PJPaula J Bretz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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