Company
United StatesHologic Incorporated, Marlborough, MA – FDA Inspections
Inspection records and compliance data for Hologic Incorporated in Marlborough, Massachusetts. 4 FDA inspections on record, last inspected June 09, 2016.
Company Profile
This profile covers Hologic Incorporated based in Marlborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected October 21, 2008. Last inspected June 9, 2016.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Failure to submit, distinct marking1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 9, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 973192 |
| September 19, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 849717 |
| May 10, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 724084 |
| October 21, 2008 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 544773 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hologic Incorporated
FEI Number
3006330030
Address
445 Simarano Dr, Marlborough, Massachusetts 01752, United States
Country
United States
ID: 94bd9044-1fbe-4b75-8d65-436aa5eafd23