Company
United StatesCranial Solutions, Pompton Lakes, NJ – FDA Inspections
Inspection records and compliance data for Cranial Solutions in Pompton Lakes, New Jersey. 4 FDA inspections on record (2 OAI), last inspected September 25, 2017.
Company Profile
This profile covers Cranial Solutions based in Pompton Lakes, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected May 14, 2010. Last inspected September 25, 2017.
Most cited issue areas
- Design control - no procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1029549 |
| April 20, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 778684 |
| January 21, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 709427 |
| May 14, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 662534 |
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
Cranial Solutions
FEI Number
3003524425
Address
602 Lincoln Ave, Pompton Lakes, New Jersey 07442, United States
Country
United States
ID: 775849c7-b399-4511-bcce-72b3620c6c40