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 1821514.
Observations3
Issue DateSeptember 28, 2011
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
Kulzer, LLC.
Location
South Bend, Indiana, United States
FEI Number
1821514
Product Type
Devices
Issue Date
September 28, 2011
Country
United States
Inspection History, 2009 to 2017
NAI2
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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