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 3002806559.
ObservationsNot available
Issue DateAugust 29, 2019
StatusNo Warning Letter
Related Inspections10
Establishment Details
Firm
Roche Diagnostics GmbH
Location
Mannheim, -
FEI Number
3002806559
Product Type
Devices
Issue Date
August 29, 2019
Country
United States
Inspection History, 2012 to 2021
NAI6
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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