FDA Inspection
The Binding Site Group, Ltd.The Binding Site Group, Ltd. – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns The Binding Site Group, Ltd., with an inspection on December 8, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- The Binding Site Group, Ltd.
- Inspection Date
- December 8, 2016
- Product Type
- Medical Devices & Rad Health
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ID · 3d1ce6a6-6384-43c0-b4da-7288d0b186d1
Inspection Facts
- Inspection number
- 994828
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of The Binding Site Group, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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