Company
United StatesSkeletal Kinetics, Llc, Addison, TX – FDA Inspections
Inspection records and compliance data for Skeletal Kinetics, Llc in Addison, Texas. 4 FDA inspections on record, 1 Form 483, last inspected October 05, 2018.
Company Profile
This profile covers Skeletal Kinetics, Llc based in Addison, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 13, 2009. Last inspected October 5, 2018.
Most cited issue areas
- Design verification - Lack of or inadequate procedures1 inspection
- Individual Report of Malfunction1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 5, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1067882 |
| September 23, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 938737 |
| July 9, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 786264 |
| November 13, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 630687 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Skeletal Kinetics, Llc
FEI Number
3003890476
Address
3885 Arapaho Rd, Addison, Texas 75001, United States
Country
United States
ID: 607f6717-d7d5-447b-92d6-cb21fab2092c