Remeda ABSeptember 14, 2023

FDA 483 - Remeda AB - September 14, 2023

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Record Details

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.

Company: Remeda AB
Inspection Date: September 14, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Tyler R. Courtney (investigator)

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ID · 3dce3b62-be80-41fd-b795-0a32db2b3caa