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Form 483

American Red Cross Blood Svcs Form 483, 2020-02-27

FDA issued a Form 483 to American Red Cross Blood Svcs on 2020-02-27 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

American Red Cross Blood Svcs · Asheville, United States · Issued February 27, 2020

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 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.

27 Feb 2020
21 CFR 606.40

Clean & orderly

Cited by Fabian N Chaparro-Rodriguez

27 Feb 2020
21 CFR 606.40

Clean & orderly

Cited by Fabian N Chaparro-Rodriguez

27 Feb 2020
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Fabian N Chaparro-Rodriguez

27 Feb 2020
21 CFR 606.60(a)

Maintain and clean equipment

Cited by Fabian N Chaparro-Rodriguez

Inspected site

ARAmerican Red Cross Blood SvcsAsheville, United States

Inspection team

FNFabian N Chaparro-Rodriguez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.40Cited across public-safe Form 483 observations2x
21 CFR 606.60(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 observations

The source PDF, 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