Company
United KingdomThe Binding Site Group, Ltd., Birmingham, United Kingdom – FDA Inspections
Inspection records and compliance data for The Binding Site Group, Ltd. in Birmingham. 2 FDA inspections on record, 1 Form 483, last inspected December 08, 2016.
Company Profile
This profile covers The Binding Site Group, Ltd. based in Birmingham, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 29, 2011. Last inspected December 8, 2016.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2016 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 994828 |
| September 29, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 747169 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
The Binding Site Group, Ltd.
FEI Number
3002808340
Address
8 Calthorpe Road, Birmingham, United Kingdom
Country
United Kingdom
ID: a952691d-5fa7-41de-a4b8-235e4ca9251a