FDA Inspection
Hologic IncorporatedHologic Incorporated – FDA Inspection, Jun 9, 2016
Record Details
This FDA Inspection record concerns Hologic Incorporated, with an inspection on June 9, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hologic Incorporated
- Inspection Date
- June 9, 2016
- Product Type
- Devices
View Company Profile
ID · 86b74abc-4576-4565-9e52-6ddafe626389
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 973192
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 1002.10Failure to submit, distinct marking
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hologic Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 10, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 21, 2008 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hologic Incorporated
- FDA Inspection 849717 - 2013-09-19
- FDA Inspection 724084 - 2011-05-10
- FDA Inspection 544773 - 2008-10-21
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