FDA Inspection
SDS Dental, Inc.SDS Dental, Inc. – FDA Inspection, Oct 31, 2014
Record Details
This FDA Inspection record concerns SDS Dental, Inc., with an inspection on October 31, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SDS Dental, Inc.
- Inspection Date
- October 31, 2014
- Product Type
- Devices
View Company Profile
ID · bb55c68c-7928-4ce0-a853-effc26dcc850
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 902259
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SDS Dental, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SDS Dental, Inc.
- FDA Inspection 969769 - 2016-03-08
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