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 1220984.
Observations1
Issue DateApril 25, 2014
Status1 Related Warning Letter
Related Inspections5
Establishment Details
Firm
Hologic, Inc.
Location
Danbury, Connecticut, United States
FEI Number
1220984
Product Type
Devices
Issue Date
April 25, 2014
Country
United States
Inspection History, 2010 to 2017
NAI2
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.