Company
United StatesHologic, Inc., Sunnyvale, CA – FDA Inspections
Inspection records and compliance data for Hologic, Inc. in Sunnyvale, California. 3 FDA inspections on record, last inspected June 28, 2017.
Company Profile
This profile covers Hologic, Inc. based in Sunnyvale, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 17, 2010. Last inspected June 28, 2017.
Most cited issue areas
- Design input - documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of System for Determining MDR Events1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2017 | Not classified | Medical Devices & Rad Health | 1034460 |
| May 24, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 835141 |
| November 17, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 698757 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hologic, Inc.
FEI Number
3001632635
Address
777 Palomar Ave, Sunnyvale, California 94085, United States
Country
United States
ID: f1027a99-79cc-42de-82f5-567b8e0cf4ed