FDA Inspection
Synergy Health North AmericaSynergy Health North America – FDA Inspection, Sep 10, 2010
Record Details
This FDA Inspection record concerns Synergy Health North America, with an inspection on September 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synergy Health North America
- Inspection Date
- September 10, 2010
- Product Type
- Devices
View Company Profile
ID · 5a44240e-b682-432e-9a57-f9722a1c921b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678063
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synergy Health North America
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Synergy Health North America
- FDA Inspection 1006425 - 2017-03-24
- FDA Inspection 819271 - 2013-02-21
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