FDA Inspection
Sam-go ProductsSam-go Products – FDA Inspection, Mar 15, 2011
Record Details
This FDA Inspection record concerns Sam-go Products, with an inspection on March 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sam-go Products
- Inspection Date
- March 15, 2011
- Product Type
- Devices
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ID · 8ca152b1-deeb-4a42-a045-19fb2a421f41
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 713034
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - 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 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Sam-go Products
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sam-go Products
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