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 1000120743.
Observations3
Issue DateNovember 04, 2025
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
Hologic, Inc
Location
Marlborough, Massachusetts
FEI Number
1000120743
Product Type
Devices
Issue Date
November 04, 2025
Country
United States
Inspection History, 2011 to 2025
NAI5
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.