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, last inspected February 02, 2023.
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
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 24, 2010. Last inspected February 2, 2023.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2023 | Not classified | Medical Devices & Rad Health | 1197368 |
| June 11, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1055241 |
| March 24, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 656265 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Datascope Corp.
FEI Number
1000222374
Address
1300 Macarthur Blvd, Mahwah, New Jersey 07430, United States
Country
United States
ID: 0b22e3d1-8ad4-4763-954b-4a86a0f1f354