Company
United StatesTherakos, Inc., West Chester, PA – FDA Inspections
Inspection records and compliance data for Therakos, Inc. in West Chester, Pennsylvania. 3 FDA inspections on record, last inspected April 22, 2015.
Company Profile
This profile covers Therakos, Inc. based in West Chester, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected February 3, 2011. Last inspected April 22, 2015.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate2 inspections
- Lack of or inadequate procedures2 inspections
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 22, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 925292 |
| May 7, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 877892 |
| February 3, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 709617 |
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
Therakos, Inc.
FEI Number
2523595
Address
10 N High St Ste 300, West Chester, Pennsylvania 19380, United States
Country
United States
ID: 1ba17068-d115-4447-b0e9-3591003da15e