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 3004582654.
Observations6
Issue DateOctober 13, 2022
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
BERLIN HEART GMBH
Location
Berlin, -, Germany
FEI Number
3004582654
Product Type
Devices
Issue Date
October 13, 2022
Country
Germany
Inspection History, 2013 to 2022
NAI1
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.
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