FDA Inspection
Surgical Design IncSurgical Design Inc – FDA Inspection, Jun 18, 2013
Record Details
This FDA Inspection record concerns Surgical Design Inc, with an inspection on June 18, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Surgical Design Inc
- Inspection Date
- June 18, 2013
- Product Type
- Devices
View Company Profile
ID · 9d7b3043-87df-4a19-8480-0a8f9ef130c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 835866
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Surgical Design Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2026 | Not classified | Baltimore District Office | Compliance: Devices |
| June 17, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Surgical Design Inc
- FDA Inspection 1331796 - 2026-08-19
- FDA Inspection 883886 - 2014-06-17
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