# FDA 483 - Hudson Scientific LLC - February 25, 2020

Source: https://www.keypedia.com/records/483/hudson-scientific-llc/c1f0cdcc-8143-463f-a695-beb122286bc6

> FDA 483 for Hudson Scientific LLC on February 25, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hudson Scientific LLC
- Inspection Date: 2020-02-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Hudson Scientific LLC in Hudson, MI, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately control nonconforming products, establish proper procedures for finished device acceptance testing documentation, and implement adequate process controls for environmental conditions and electrostatic discharge. These issues indicate a lack of robust quality management practices.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/hudson-scientific-llc/d22fea7c-847c-4484-86d1-abd0f15697e3

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0