# FDA 483 - Kattegat Llc - October 13, 2021

Source: https://www.keypedia.com/records/483/kattegat-llc/db8e4b84-40fd-4526-ae3b-f7e576b1e0f7

> FDA 483 for Kattegat Llc on October 13, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kattegat Llc
- Inspection Date: 2021-10-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Kattegat Llc, a medical device distributor in Valley Stream, NY, revealed significant deficiencies in their quality system. The firm failed to maintain complaint files, establish design control procedures, and implement adequate supplier oversight for their (b)(4) compression sock. These observations indicate a lack of fundamental controls necessary for ensuring device quality and regulatory compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/kattegat-llc/d946b29a-b294-4c4b-9c12-d344876d18ac

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