483
Linxens Sweden ABFDA 483 - Linxens Sweden AB - November 07, 2024
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Linxens Sweden AB, a medical device manufacturer in Angelholm Skane, was inspected by the FDA from November 4-7, 2024. The inspection revealed two significant issues related to quality system deficiencies. Specifically, the firm lacked established procedures for design transfer and failed to adequately document process validation activities and results.
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ID · 5d9e6d1a-3b40-4b8b-aa91-c4dcf7770054