FDA Inspection
Novum Medical Products of NY, LLCNovum Medical Products of NY, LLC – FDA Inspection, Oct 10, 2008
Record Details
This FDA Inspection record concerns Novum Medical Products of NY, LLC, with an inspection on October 10, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 10, 2008
- Product Type
- Devices
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ID · dbb2de59-1e59-4a2f-8382-95d30ff8d954
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 544396
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.100(a)(3)Identifying corrective & preventive actions
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of Novum Medical Products of NY, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 |
Other documents for Novum Medical Products of NY, LLC
- FDA Inspection 1224321 - 2023-12-05
- FDA Inspection 1146297 - 2021-07-13
- FDA Inspection 1059360 - 2018-07-13
- FDA Inspection 904962 - 2014-11-06
- FDA Inspection 855744 - 2013-11-15
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