FDA Inspection
Zyga Technology, Inc.Zyga Technology, Inc. – FDA Inspection, Oct 3, 2012
Record Details
This FDA Inspection record concerns Zyga Technology, Inc., with an inspection on October 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zyga Technology, Inc.
- Inspection Date
- October 3, 2012
- Product Type
- Devices
View Company Profile
ID · 29b38cba-d897-42a0-a3c5-135038d3fe27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803692
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Zyga Technology, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zyga Technology, Inc.
- FDA Inspection 1040488 - 2018-02-07
- FDA Inspection 937015 - 2015-07-22
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