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 2416455.
Observations2
Issue DateMay 22, 2013
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
Coltene Whaledent Inc
Location
Cuyahoga Falls, Ohio, United States
FEI Number
2416455
Product Type
Devices
Issue Date
May 22, 2013
Country
United States
Inspection History, 2009 to 2016
NAI2
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.