# FDA 483 - Novum Medical Products of NY, LLC - December 05, 2023

Source: https://www.globalkeysolutions.net/records/483/novum-medical-products-of-ny-llc/f2f93b93-43fc-4baa-9682-4e6f3d2efbcc

> FDA 483 for Novum Medical Products of NY, LLC on December 05, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novum Medical Products of NY, LLC
- Inspection Date: 2023-12-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Novum Medical Products of NY, LLC, a medical device manufacturer in Amherst, NY, received a Form FDA 483 with one repeat observation. The inspection revealed inadequacies in the firm's corrective and preventive action (CAPA) procedures, specifically concerning the verification of effectiveness and comprehensive issue resolution. This indicates a persistent issue with their quality system.

## Related Documents

- [483 - 2021-07-13](https://www.globalkeysolutions.net/records/483/novum-medical-products-of-ny-llc/f902bfe3-c6f6-48d2-beae-58920311c836)
- [483 - 2023-12-05](https://www.globalkeysolutions.net/records/483/novum-medical-products-of-ny-llc/260b33bb-c169-4d52-ade5-4432b72058dc)

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/novum-medical-products-of-ny-llc/7e391af6-9876-4410-aad2-d191ad752d77

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961