Atlas

Form 483

DCI Donor Services dba Tennessee Donor Services Form 483, 2013-12-19

FDA issued a Form 483 to DCI Donor Services dba Tennessee Donor Services on 2013-12-19 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

DCI Donor Services dba Tennessee Donor Services · Nashville, United States · Issued December 19, 2013

Overview

  • 2 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.

19 Dec 2013
21 CFR 1271.200(b)

Procedures inadequate

Cited by Lacey J Chessor

19 Dec 2013
21 CFR 1271.230(a)

Validation & approval--established procedures

Cited by Lacey J Chessor

Inspected site

DDDCI Donor Services dba Tennessee Donor ServicesNashville, United States

Inspection team

LJLacey J Chessor

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.200(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.230(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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