Atlas

Form 483

Carter BloodCare - Tyler Form 483, 2009-10-20

FDA issued a Form 483 to Carter BloodCare - Tyler on 2009-10-20 with 3 public-safe observations.

483· Form 483 issued3 observations

Carter BloodCare - Tyler · Tyler, United States · Issued October 20, 2009

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.

20 Oct 2009
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Iris C Macinnes

20 Oct 2009
21 CFR 606.60(a)

Provide proper equipment to meet requirements

Cited by Iris C Macinnes

20 Oct 2009
21 CFR 606.100(c)

Thorough investigations

Cited by Iris C Macinnes

Inspected site

CBCarter BloodCare - TylerTyler, United States

Inspection team

ICIris C Macinnes

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x
21 CFR 606.60(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