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 2024800.
Observations4
Issue DateOctober 14, 2022
Status1 Related Warning Letter
Related Inspections10
Establishment Details
Firm
Hologic, Inc.
Location
San Diego, California, United States
FEI Number
2024800
Product Type
Devices
Issue Date
October 14, 2022
Country
United States
Inspection History, 2013 to 2024
NAI6
VAI3
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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