FDA Inspection
Novum Medical Products of NY, LLCNovum Medical Products of NY, LLC – FDA Inspection, Dec 5, 2023
Record Details
This FDA Inspection record concerns Novum Medical Products of NY, LLC, with an inspection on December 5, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dd3cc607-570f-4456-9ae9-00112e4d5a14
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1224321
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Novum Medical Products of NY, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 13, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Novum Medical Products of NY, LLC
- FDA Inspection 1146297 - 2021-07-13
- FDA Inspection 1059360 - 2018-07-13
- FDA Inspection 904962 - 2014-11-06
- FDA Inspection 855744 - 2013-11-15
- FDA Inspection 763376 - 2012-01-13
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