Company
United StatesTYRX Inc., Monmouth Junction, NJ – FDA Inspections
Inspection records and compliance data for TYRX Inc. in Monmouth Junction, New Jersey. 4 FDA inspections on record (2 OAI), 1 Form 483, last inspected February 27, 2018.
Company Profile
This profile covers TYRX Inc. based in Monmouth Junction, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 22, 2010. Last inspected February 27, 2018.
Most cited issue areas
- DHR content2 inspections
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate process validation2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 27, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1042512 |
| February 12, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 968601 |
| March 26, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 824116 |
| June 22, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 668090 |
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
TYRX Inc.
FEI Number
3005619263
Address
1 Deerpark Dr Ste G, Monmouth Junction, New Jersey 08852, United States
Country
United States
ID: 3257e162-6570-44f9-874d-fefa6815c152