FDA Inspection
Hologic, Inc.Hologic, Inc. – FDA Inspection, Nov 17, 2010
Record Details
This FDA Inspection record concerns Hologic, Inc., with an inspection on November 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hologic, Inc.
- Inspection Date
- November 17, 2010
- Product Type
- Devices
View Company Profile
ID · 938690d6-3af2-43c3-b7a3-1b7d4273a279
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 698757
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hologic, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2017 | Not classified | San Francisco District Office | |
| May 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hologic, Inc.
- FDA Inspection 1034460 - 2017-06-28
- FDA Inspection 835141 - 2013-05-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.