483
TacPro LLCFDA 483 - TacPro LLC - February 22, 2024
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An FDA inspection of Creganna Medical, Inc. in Plymouth, MN, revealed that procedures for training and identifying training needs were not adequately established. Specifically, operators were observed deviating from documented work instructions during the manufacturing of catheter products. These deviations indicate a failure to ensure personnel are properly trained to perform their assigned responsibilities.
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ID · 43808c4a-e143-4f34-8c17-5581920b98a8