FDA Inspection
Acteon, Inc.Acteon, Inc. – FDA Inspection, Dec 10, 2014
Record Details
This FDA Inspection record concerns Acteon, Inc., with an inspection on December 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Acteon, Inc.
- Inspection Date
- December 10, 2014
- Product Type
- Devices
View Company Profile
ID · 7fc0adc6-924b-4c45-ad96-e8574b5ca69b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 905889
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Acteon, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 12, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Acteon, Inc.
- FDA Inspection 1002018 - 2017-02-23
- FDA Inspection 756655 - 2011-12-12
- FDA Inspection 595046 - 2009-07-09
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