Company
United StatesNorland At Swissray, Mahwah, NJ – FDA Inspections
Inspection records and compliance data for Norland At Swissray in Mahwah, New Jersey. 3 FDA inspections on record (1 OAI), last inspected July 30, 2012.
Company Profile
This profile covers Norland At Swissray based in Mahwah, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 20, 2010. Last inspected July 30, 2012.
Most cited issue areas
- Production and Process Change Procedures, lack of or Inad.2 inspections
- Design validation- Lack of or inadequate procedures1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 30, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 793047 |
| September 13, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 742300 |
| September 20, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 681173 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Norland At Swissray
FEI Number
2124648
Address
1 International Blvd Ste 400, Mahwah, New Jersey 07495, United States
Country
United States
ID: d758d595-c93b-4073-b13e-0f78527daed4