FDA 483 - Remeda AB - September 14, 2023

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.