Company
United StatesNovum Medical Products of NY, LLC, Amherst, NY – FDA Inspections
Inspection records and compliance data for Novum Medical Products of NY, LLC in Amherst, New York. 7 FDA inspections on record, 2 Form 483s, last inspected December 05, 2023.
Company Profile
This profile covers Novum Medical Products of NY, LLC based in Amherst, New York, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 5
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected October 10, 2008. Last inspected December 5, 2023.
Most cited issue areas
- DHR content2 inspections
- Lack of or inadequate procedures2 inspections
- Management review - Lack of or inadequate procedures2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 5, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1224321 |
| July 13, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1146297 |
| July 13, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1059360 |
| November 6, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 904962 |
| November 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 855744 |
| January 13, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 763376 |
| October 10, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 544396 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Novum Medical Products of NY, LLC
FEI Number
1318843
Address
80 Creekside Dr, Amherst, New York 14228, United States
Country
United States
ID: 7e391af6-9876-4410-aad2-d191ad752d77