Company
United StatesIntelligent Implant Systems, Charlotte, NC – FDA Inspections
Inspection records and compliance data for Intelligent Implant Systems in Charlotte, North Carolina. 1 FDA inspection on record, 1 Form 483, last inspected July 16, 2018.
Company Profile
This profile covers Intelligent Implant Systems based in Charlotte, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected July 16, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - production units1 inspection
- Design verification - documentation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 16, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1058966 |
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
Intelligent Implant Systems
FEI Number
3011121367
Address
3300 International Airport Dr Ste 1100, Charlotte, North Carolina 28208, United States
Country
United States
ID: f847fd24-8a9e-4489-bfd0-d5e83ef63592