Company
United StatesSurgical Concept Designs, Hackensack, NJ – FDA Inspections
Inspection records and compliance data for Surgical Concept Designs in Hackensack, New Jersey. 1 FDA inspection on record, last inspected September 23, 2011.
Company Profile
This profile covers Surgical Concept Designs based in Hackensack, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected September 23, 2011.
Most cited issue areas
- Design verification - Lack of or inadequate procedures1 inspection
- Documented evaluation1 inspection
- Servicing - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 23, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 746130 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Surgical Concept Designs
FEI Number
3007411440
Address
307 Prospect Ave Apt 2G, Hackensack, New Jersey 07601, United States
Country
United States
ID: 763ac4b3-5008-4bee-a81f-1de2d3c16197