FDA Inspection
Sandare International, IncFDA Inspection 1022963 - Sandare International, Inc - August 24, 2017
Record Details
This FDA Inspection record concerns Sandare International, Inc, with an inspection on August 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sandare International, Inc
- Inspection Date
- August 24, 2017
- Product Type
- Devices
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ID · d3f52a4a-d844-4257-8ca9-1f9a1d231fc4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022963
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Sandare International, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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