Company
United StatesDiagnostics Direct LLC, Stone Harbor, NJ – FDA Inspections
Inspection records and compliance data for Diagnostics Direct LLC in Stone Harbor, New Jersey. 2 FDA inspections on record, 1 Form 483, last inspected August 30, 2017.
Company Profile
This profile covers Diagnostics Direct LLC based in Stone Harbor, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected July 3, 2013. Last inspected August 30, 2017.
Most cited issue areas
- Lack of or inadequate receiving acceptance procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 30, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1023448 |
| July 3, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 851750 |
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
Diagnostics Direct LLC
FEI Number
3009178048
Address
373 96th St Unit C, Stone Harbor, New Jersey 08247-1408, United States
Country
United States
ID: 18bb832c-8d5d-4ff0-b22e-65bb6348ca13