Atlas

Form 483

American Red Cross Donor And Client Support Center Form 483, 2014-10-31

FDA issued a Form 483 to American Red Cross Donor And Client Support Center on 2014-10-31 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

American Red Cross Donor And Client Support Center · Philadelphia, United States · Issued October 31, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

31 Oct 2014
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Erika M Wilkerson, Gayle S Lawson, Megan M Lauff

31 Oct 2014
21 CFR 606.100(c)

Thorough investigations

Cited by Erika M Wilkerson, Gayle S Lawson, Megan M Lauff

31 Oct 2014
21 CFR 630.40(b)(3)

Results of testing

Cited by Erika M Wilkerson, Gayle S Lawson, Megan M Lauff

Inspected site

ARAmerican Red Cross Donor And Client Support CenterPhiladelphia, United States

Inspection team

EMErika M Wilkerson
GSGayle S Lawson
MMMegan M Lauff

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
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