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Form 483

The Community Blood Center, Inc. Form 483, 2020-03-04

FDA issued a Form 483 to The Community Blood Center, Inc. on 2020-03-04 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

The Community Blood Center, Inc. · Appleton, United States · Issued March 4, 2020

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.

4 Mar 2020
21 CFR 606.100(c)

Thorough investigations

Cited by Elizabeth B Griffin

4 Mar 2020
21 CFR 606.100(c)

Thorough investigations

Cited by Elizabeth B Griffin

Inspected site

TCThe Community Blood Center, Inc.Appleton, United States

Inspection team

EBElizabeth B Griffin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations2x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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