# FDA 483 - Novum Medical Products of NY, LLC - July 13, 2021

Source: https://www.globalkeysolutions.net/records/483/novum-medical-products-of-ny-llc/f902bfe3-c6f6-48d2-beae-58920311c836

> FDA 483 for Novum Medical Products of NY, LLC on July 13, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Novum Medical Products of NY, LLC
- Inspection Date: 2021-07-13
- Product Type: device
- Office Name: Office of Human and Animal Foods Operations - East
- Summary: Novum Medical Products of NY, LLC, a medical device manufacturer in Amherst, NY, was inspected by the FDA from July 9-13, 2021. The inspection revealed deficiencies in the firm's quality system, specifically concerning the establishment and implementation of corrective and preventive action procedures and document control procedures. These issues indicate a need for improved adherence to quality system regulations for medical device manufacturing.

## Related Documents

- [483 - 2023-12-05](https://www.globalkeysolutions.net/records/483/novum-medical-products-of-ny-llc/f2f93b93-43fc-4baa-9682-4e6f3d2efbcc)
- [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/office-of-human-and-animal-foods-operations-east/f35344fc-4cf2-4605-b1cf-163d65050588