Atlas

Form 483

The American National Red Cross Form 483, 2011-06-08

FDA issued a Form 483 to The American National Red Cross on 2011-06-08 with 2 public-safe observations.

483· Form 483 issued2 observations

The American National Red Cross · Lewiston, United States · Issued June 8, 2011

Overview

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

Inspectional observations

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

8 Jun 2011
21 CFR 606.65(e)

Following manufacturer's instructions

Cited by Mark W Babbitt, Dianna D Wardlow-Dotter

8 Jun 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Mark W Babbitt, Dianna D Wardlow-Dotter

Inspected site

TAThe American National Red CrossLewiston, United States

Inspection team

MWMark W Babbitt
DDDianna D Wardlow-Dotter

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 606.65(e)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