Company
United StatesDatascope Corp., Mahwah, NJ – FDA Inspections
Inspection records and compliance data for Datascope Corp. in Mahwah, New Jersey. 1 FDA inspection on record (1 OAI), last inspected October 17, 2013.
Company Profile
This profile covers Datascope Corp. based in Mahwah, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected October 17, 2013.
Most cited issue areas
- Lack of or inadequate procedures for labeling1 inspection
- Management review - defined interval, sufficient frequency1 inspection
- Nonconforming product control1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 17, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 853578 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Datascope Corp.
FEI Number
3009540546
Address
1300 Macarthur Blvd, Mahwah, New Jersey 07430, United States
Country
United States
ID: a310b512-57d1-4093-adf5-694e5cfe7897