Company
United StatesDatascope Corp., Mahwah, NJ – FDA Inspections
Inspection records and compliance data for Datascope Corp. in Mahwah, New Jersey. 3 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected October 03, 2018.
Company Profile
This profile covers Datascope Corp. based in Mahwah, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected April 1, 2010. Last inspected October 3, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - output does not meet input requirement1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 3, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1071011 |
| April 13, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 657359 |
| April 1, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 656388 |
FDA documents
Form 483s (1)
Warning Letters (1)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Datascope Corp.
FEI Number
3001418283
Address
1300 Macarthur Blvd, Mahwah, New Jersey 07430, United States
Country
United States
ID: fb84709f-8911-4733-99a2-fa448d2f6272