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 1028232.
Observations1
Issue DateMay 06, 2013
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
BIOTRONIK Inc
Location
Lake Oswego, Oregon, United States
FEI Number
1028232
Product Type
Devices
Issue Date
May 06, 2013
Country
United States
Inspection History, 2009 to 2022
NAI3
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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