Atlas

Form 483

DCI Donor Services, Inc. Form 483, 2011-12-19

FDA issued a Form 483 to DCI Donor Services, Inc. on 2011-12-19 with 3 public-safe observations.

483· Form 483 issued3 observations

DCI Donor Services, Inc. · Nashville, United States · Issued December 19, 2011

Overview

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

Inspectional observations

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

19 Dec 2011
21 CFR 1271.160(b)(6)

Deviations--evaluation, cause, corrective action

Cited by Whitney White, Danielle M Maddox

19 Dec 2011
21 CFR 1271.180(a)

Procedures to meet core CTGP

Cited by Whitney White, Danielle M Maddox

19 Dec 2011
21 CFR 1271.195(b)

Corrective actions

Cited by Whitney White, Danielle M Maddox

Inspected site

DDDCI Donor Services, Inc.Nashville, United States

Inspection team

WWWhitney White
DMDanielle M Maddox

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.160(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 1271.180(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.195(b)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