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Form 483

Roche Diagnostics Corporation Form 483, 2019-06-27

FDA issued a Form 483 to Roche Diagnostics Corporation on 2019-06-27 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Roche Diagnostics Corporation · Indianapolis, United States · Issued June 27, 2019

Overview

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

Inspectional observations

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

27 Jun 2019
21 CFR 812.40

Sponsors' general responsibilities

Cited by Myra K Casey, Juliane C Lessard

27 Jun 2019
21 CFR 812.40

Sponsors' general responsibilities

Cited by Myra K Casey, Juliane C Lessard

Inspected site

RDRoche Diagnostics CorporationIndianapolis, United States

Inspection team

MKMyra K Casey
JCJuliane C Lessard

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.40Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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