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Form 483

University Of Michigan Form 483, 2018-12-14

FDA issued a Form 483 to University Of Michigan on 2018-12-14 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

University Of Michigan · Ann Arbor, United States · Issued December 14, 2018

Overview

  • 5 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.

14 Dec 2018
FDCA 501(a)(2)(A)

Disinfecting materials, aseptic processing area

Cited by Emily J Orban

14 Dec 2018
FDCA 501(a)(2)(A)

Disruption of airflow from personnel movement

Cited by Emily J Orban

14 Dec 2018
FDCA 501(a)(2)(A)

Exposure of personnel in aspectic processing

Cited by Emily J Orban

14 Dec 2018
FDCA 501(a)(2)(A)

Flow of personnel and materials, facility

Cited by Emily J Orban

14 Dec 2018
FDCA 501(a)(2)(A)

Inadequate sporicidal agents, cleanroom and ISO 5 area

Cited by Emily J Orban

Inspected site

UOUniversity Of MichiganAnn Arbor, United States

Inspection team

EJEmily J Orban

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 501(a)(2)(A)Cited across public-safe Form 483 observations5x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 5 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