Company
United StatesNextPhase Medical Devices, Waldwick, NJ – FDA Inspections
Inspection records and compliance data for NextPhase Medical Devices in Waldwick, New Jersey. 4 FDA inspections on record, 1 Form 483, last inspected December 06, 2016.
Company Profile
This profile covers NextPhase Medical Devices based in Waldwick, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 5, 2008. Last inspected December 6, 2016.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 6, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 998478 |
| June 21, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 787295 |
| August 18, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 608671 |
| December 5, 2008 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 550580 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
NextPhase Medical Devices
FEI Number
3002882053
Address
150 Hopper Ave, Waldwick, New Jersey 07463, United States
Country
United States
ID: b0a447a9-c125-4752-857e-7314547ecb43