FDA Inspection
BioCeramics Restorative MaterialsBioCeramics Restorative Materials – FDA Inspection, Aug 26, 2016
Record Details
This FDA Inspection record concerns BioCeramics Restorative Materials, with an inspection on August 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 26, 2016
- Product Type
- Devices
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ID · c8e0833f-e87a-4f02-944e-5d0e0b3c8792
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983251
- 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(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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