Company
United StatesInstratek, Incorporated, Houston, TX – FDA Inspections
Inspection records and compliance data for Instratek, Incorporated in Houston, Texas. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected March 24, 2014.
Company Profile
This profile covers Instratek, Incorporated based in Houston, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected April 24, 2012. Last inspected March 24, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design history file1 inspection
- Design review - documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 24, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 868891 |
| April 24, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 778209 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Instratek, Incorporated
FEI Number
1000118334
Address
15200 Middlebrook Dr Ste G, Houston, Texas 77058, United States
Country
United States
ID: c0990f82-062b-4856-a726-04e2d0a90a36