FDA Inspection
Sagemax Bioceramics, Inc.Sagemax Bioceramics, Inc. – FDA Inspection, Jul 2, 2010
Record Details
This FDA Inspection record concerns Sagemax Bioceramics, Inc., with an inspection on July 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sagemax Bioceramics, Inc.
- Inspection Date
- July 2, 2010
- Product Type
- Devices
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ID · aecc4371-30d0-4b3c-b7c6-445fa3a0bce4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672024
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Maintained
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Other FDA inspections of Sagemax Bioceramics, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 18, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 24, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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