Atlas

Form 483

The Community Blood Center, Inc. Form 483, 2009-10-14

FDA issued a Form 483 to The Community Blood Center, Inc. on 2009-10-14 with 3 public-safe observations.

483· Form 483 issued3 observations

The Community Blood Center, Inc. · Appleton, United States · Issued October 14, 2009

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.

14 Oct 2009
21 CFR 600.14(c)

When to report

Cited by Melissa J Holz

14 Oct 2009
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Melissa J Holz

14 Oct 2009
21 CFR 630.40(b)(3)

Results of testing

Cited by Melissa J Holz

Inspected site

TCThe Community Blood Center, Inc.Appleton, United States

Inspection team

MJMelissa J Holz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 600.14(c)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 630.40(b)(3)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