Atlas

Form 483

CareFusion DR 203 LTD Form 483, 2016-05-05

FDA issued a Form 483 to CareFusion DR 203 LTD on 2016-05-05 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

CareFusion DR 203 LTD · Santo Domingo, Dominican Republic (the) · Issued May 5, 2016

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.

5 May 2016
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Roy Baby

5 May 2016
21 CFR 820.75(b)

Lack/Inad procedure-Monitoring/Control of Validated Proces

Cited by Roy Baby

Inspected site

CDCareFusion DR 203 LTDSanto Domingo, Dominican Republic (the)

Inspection team

RBRoy Baby

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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