Atlas

Form 483

The American National Red Cross Form 483, 2014-06-26

FDA issued a Form 483 to The American National Red Cross on 2014-06-26 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

The American National Red Cross · Worcester, United States · Issued June 26, 2014

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

26 Jun 2014
21 CFR 640.25(a)

Storage temps./agitation

Cited by Lorayne A Mcguinness, Alice C Silva

Inspected site

TAThe American National Red CrossWorcester, United States

Inspection team

LALorayne A Mcguinness
ACAlice C Silva

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 640.25(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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