Company
United StatesWright Therapy Products, Inc., Oakdale, PA – FDA Inspections
Inspection records and compliance data for Wright Therapy Products, Inc. in Oakdale, Pennsylvania. 4 FDA inspections on record, last inspected June 01, 2015.
Company Profile
This profile covers Wright Therapy Products, Inc. based in Oakdale, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected December 9, 2009. Last inspected June 1, 2015.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - documentation1 inspection
- Design validation - software validation not performed1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 1, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 926621 |
| June 28, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 838640 |
| August 18, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 739277 |
| December 9, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 623425 |
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
Wright Therapy Products, Inc.
FEI Number
2522937
Address
103b International Dr, Oakdale, Pennsylvania 15071, United States
Country
United States
ID: 79866f4c-153d-4dfd-b499-e08ce39bf4c1