Company
United StatesHologic, Inc, Marlborough, MA – FDA Inspections
Inspection records and compliance data for Hologic, Inc in Marlborough, Massachusetts. 7 FDA inspections on record (2 OAI), 3 Form 483s, last inspected November 04, 2025.
Company Profile
This profile covers Hologic, Inc based in Marlborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 2
- VAI
- 0
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected February 23, 2011. Last inspected November 4, 2025.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design history file1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 4, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1290240 |
| September 24, 2024 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1240946 |
| November 30, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1035885 |
| June 29, 2017 | Not classified | Medical Devices & Rad Health | 1034462 |
| September 26, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 850106 |
| May 10, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 724038 |
| February 23, 2011 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 712158 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hologic, Inc
FEI Number
1000120743
Address
250 Campus Dr, Marlborough, Massachusetts 01752, United States
Country
United States
ID: 4d48f318-a95f-441e-9118-6ce684212e08