Roche Diagnostics Operations, Inc.

Form 483FOIA Uncovered

Indianapolis, Indiana, United StatesFEI 1823260Issued June 27, 2019

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1823260.

Observations1

Issue DateJune 27, 2019

StatusNo Warning Letter

Related Inspections9

Establishment Details

Firm: Roche Diagnostics Operations, Inc.
Location: Indianapolis, Indiana, United States
FEI Number: 1823260
Product Type: Devices
Issue Date: June 27, 2019
Country: United States

Inspection History, 2010 to 2022

NAI7

VAI2

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

Act on This Form 483

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Roche Diagnostics Operations, Inc. FDA Form 483, Indianapolis, Indiana, June 27, 2019