Company
United StatesDirex Systems Corp., Canton, MA – FDA Inspections
Inspection records and compliance data for Direx Systems Corp. in Canton, Massachusetts. 3 FDA inspections on record, 1 Form 483, last inspected April 12, 2017.
Company Profile
This profile covers Direx Systems Corp. based in Canton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 4, 2012. Last inspected April 12, 2017.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Management review - Lack of or inadequate procedures1 inspection
- Service reports1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2017 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1007613 |
| October 8, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 899351 |
| April 4, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 775404 |
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
Direx Systems Corp.
FEI Number
1000513552
Address
956 Turnpike St, Canton, Massachusetts 02021, United States
Country
United States
ID: 032cf35f-f13b-4380-8bf7-089beb0314d8