Company
United StatesNytone Medical Products, Inc., Bluffdale, UT – FDA Inspections
Inspection records and compliance data for Nytone Medical Products, Inc. in Bluffdale, Utah. 3 FDA inspections on record, 1 Form 483, last inspected June 05, 2017.
Company Profile
This profile covers Nytone Medical Products, Inc. based in Bluffdale, Utah, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 5, 2009. Last inspected June 5, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design history file1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1012840 |
| January 10, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 861881 |
| June 5, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 588881 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Nytone Medical Products, Inc.
FEI Number
1718047
Address
14621 S 800 W Ste 400, Bluffdale, Utah 84065, United States
Country
United States
ID: f3ed71d0-a781-4da9-b446-dd0f5777853e