Atlas

Form 483

American National Red Cross (The) Carolinas Region Form 483, 2014-06-19

FDA issued a Form 483 to American National Red Cross (The) Carolinas Region on 2014-06-19 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

American National Red Cross (The) Carolinas Region · Charlotte, United States · Issued June 19, 2014

Overview

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

Inspectional observations

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

19 Jun 2014
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Brandy D Brown, Randy L Clarida, Cordelia J Brammer, Brandy Davis Brown

19 Jun 2014
21 CFR 606.100(b)(15)

Schedules and procedures for equipment & calibration

Cited by Brandy D Brown, Randy L Clarida, Cordelia J Brammer, Brandy Davis Brown

19 Jun 2014
21 CFR 606.160(a)(1)

Person performing, test results, interpretation

Cited by Brandy D Brown, Randy L Clarida, Cordelia J Brammer, Brandy Davis Brown

Inspected site

ANAmerican National Red Cross (The) Carolinas RegionCharlotte, United States

Inspection team

BDBrandy D Brown
RLRandy L Clarida
CJCordelia J Brammer
BDBrandy Davis Brown

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(b)(15)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)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