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 3005900820.
Observations1
Issue DateOctober 21, 2021
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
Cochlear Americas Inc.
Location
Lone Tree, Colorado, United States
FEI Number
3005900820
Product Type
Devices
Issue Date
October 21, 2021
Country
United States
Inspection History, 2009 to 2021
NAI4
VAI1
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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