Company
United StatesOtotronix, LLC, Spring, TX – FDA Inspections
Inspection records and compliance data for Ototronix, LLC in Spring, Texas. 2 FDA inspections on record, last inspected August 16, 2013.
Company Profile
This profile covers Ototronix, LLC based in Spring, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 10, 2011. Last inspected August 16, 2013.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - software validation not performed1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 16, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 842199 |
| November 10, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 753121 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ototronix, LLC
FEI Number
3008612563
Address
26620 Interstate 45, Spring, Texas 77386, United States
Country
United States
ID: 496d228b-b4f3-4f30-9696-6d19d3d19ca1