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 1221300.
Observations1
Issue DateApril 15, 2013
Status1 Related Warning Letter
Related Inspections4
Establishment Details
Firm
Hologic, Inc.
Location
Bedford, Massachusetts, United States
FEI Number
1221300
Product Type
Devices
Issue Date
April 15, 2013
Country
United States
Inspection History, 2011 to 2016
NAI2
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.