FDA Inspection
Hooper Holmes, Inc.Hooper Holmes, Inc. – FDA Inspection, Mar 7, 2013
Record Details
This FDA Inspection record concerns Hooper Holmes, Inc., with an inspection on March 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hooper Holmes, Inc.
- Inspection Date
- March 7, 2013
- Product Type
- Devices
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ID · c6bc7e50-fac0-4f39-aeeb-3fe8543a15f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821760
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Hooper Holmes, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 18, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 23, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hooper Holmes, Inc.
- FDA Inspection 1019167 - 2017-07-26
- FDA Inspection 730902 - 2011-06-17
- FDA Inspection 719276 - 2011-04-18
- FDA Inspection 670528 - 2010-06-23
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