Company
United StatesNovamed USA, Inc., Elmsford, NY – FDA Inspections
Inspection records and compliance data for Novamed USA, Inc. in Elmsford, New York. 3 FDA inspections on record, last inspected January 25, 2017.
Company Profile
This profile covers Novamed USA, Inc. based in Elmsford, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected May 7, 2009. Last inspected January 25, 2017.
Most cited issue areas
- DHR content1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
- Quality Audit/Reaudit - conducted1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 25, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 998087 |
| September 6, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 797903 |
| May 7, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 585988 |
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
Novamed USA, Inc.
FEI Number
1000521377
Address
4 Westchester Plz, Elmsford, New York 10523, United States
Country
United States
ID: fd9b24d2-4d64-4585-8b20-fe5f57aab58e