Atlas

Form 483

Carter BloodCare Form 483, 2010-10-15

FDA issued a Form 483 to Carter BloodCare on 2010-10-15 with 3 public-safe observations.

483· Form 483 issued3 observations

Carter BloodCare · Flower Mound, United States · Issued October 15, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

15 Oct 2010
21 CFR 606.65(e)

Following manufacturer's instructions

Cited by Tracy J Washington

15 Oct 2010
21 CFR 606.100(c)

Thorough investigations

Cited by Tracy J Washington

15 Oct 2010
21 CFR 640.21(a)

Eligibility of platelet donors

Cited by Tracy J Washington

Inspected site

CBCarter BloodCareFlower Mound, United States

Inspection team

TJTracy J Washington

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x
21 CFR 606.65(e)Cited across public-safe Form 483 observations1x
21 CFR 640.21(a)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