FDA Inspection
Somnetics International, Inc.Somnetics International, Inc. – FDA Inspection, Jul 17, 2012
Record Details
This FDA Inspection record concerns Somnetics International, Inc., with an inspection on July 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 17, 2012
- Product Type
- Devices
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ID · ee7650ee-70f8-4dd8-ad2d-ddb9dba81587
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791140
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Somnetics International, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Somnetics International, Inc.
- FDA Inspection 937197 - 2015-07-28
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