Company
United StatesDiopsys, Inc., Cedar Knolls, NJ – FDA Inspections
Inspection records and compliance data for Diopsys, Inc. in Cedar Knolls, New Jersey. 3 FDA inspections on record, last inspected November 02, 2015.
Company Profile
This profile covers Diopsys, Inc. based in Cedar Knolls, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 1, 2010. Last inspected November 2, 2015.
Most cited issue areas
- Design review - Lack of or inadequate procedures2 inspections
- DMR device specifications2 inspections
- Complete files maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 2, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 947353 |
| August 11, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 744141 |
| March 1, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 651054 |
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
Diopsys, Inc.
FEI Number
3004174467
Address
2 Wing Dr Ste 2a, Cedar Knolls, New Jersey 07927, United States
Country
United States
ID: a6eb8d0b-f529-46e2-9151-6446754886be