Atlas

Form 483

The American National Red Cross Form 483, 2017-07-07

FDA issued a Form 483 to The American National Red Cross on 2017-07-07 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

The American National Red Cross · Louisville, United States · Issued July 7, 2017

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.

7 Jul 2017
21 CFR 606.60(b)

Equipment calibration frequency

Cited by Leena Thomas

7 Jul 2017
21 CFR 606.60(b)

Equipment calibration frequency

Cited by Leena Thomas

Inspected site

TAThe American National Red CrossLouisville, United States

Inspection team

LTLeena Thomas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.60(b)Cited across public-safe Form 483 observations2x

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