483
Teleflex Medical Europe LtdTeleflex Medical Europe Ltd – FDA 483, May 5, 2017
Record Details
Teleflex Medical Europe Ltd in Athlone, Ireland, was inspected from May 2-5, 2017, revealing inadequacies in their design change procedures. The firm failed to adequately establish procedures for design changes, specifically concerning documentation and cross-referencing between various internal control documents. This indicates a moderate severity issue related to their quality system for medical device development.
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ID · 46bdc9ce-0573-4d65-b5e0-ebf06e34f28c
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