# FDA 483 - Remeda AB - September 14, 2023

Source: https://www.keypedia.com/records/483/remeda-ab/3dce3b62-be80-41fd-b795-0a32db2b3caa

> FDA 483 for Remeda AB on September 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Remeda AB
- Inspection Date: 2023-09-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Remeda AB, a manufacturer in Halmstad, Sweden, received an FDA Form 483 following an inspection from September 11-14, 2023. The inspection revealed a significant quality system deficiency related to the control of nonconforming products. Specifically, the firm failed to adequately establish and document procedures for the rework of nonconforming products, leading to undocumented ad-hoc rework operations.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.keypedia.com/companies/remeda-ab/ebd3fd12-2e45-4db1-ac11-1ddbc695a7c7

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd