# FDA 483 - Elite Medical Supply of New York, LLC - February 11, 2020

Source: https://www.keypedia.com/records/483/elite-medical-supply-of-new-york-llc/56a5549e-95fc-4cec-971a-43bf882bd6c3

> FDA 483 for Elite Medical Supply of New York, LLC on February 11, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elite Medical Supply of New York, LLC
- Inspection Date: 2020-02-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Elite Medical Supply of New York, LLC, a medical device specification developer in West Seneca, NY, identified a significant quality control issue. The firm's procedures for accepting incoming product were found to be inadequate. Specifically, the inspection revealed that the company's incoming inspection work instructions allowed for re-sampling and acceptance of a lot even if the initial sample failed to meet specified requirements.

## Related Officers

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

Company: https://www.keypedia.com/companies/elite-medical-supply-of-new-york-llc/1998ae3a-0541-46ba-9ad4-c75de3919cad

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