483
SMITHS MEDICAL ASD, INC.SMITHS MEDICAL ASD, INC. – FDA 483, Jun 9, 2023
Record Details
An FDA inspection of Smiths Medical ASD, Inc. in Oakdale, MN, revealed significant deficiencies in process control procedures and the handling of nonconforming products. Operators were found to be deviating from established testing protocols, and the firm's investigation into nonconformances failed to adequately identify all potentially affected products, some of which were distributed. These issues indicate a breakdown in quality system adherence and oversight.
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ID · fcc7c9db-a55d-42fe-a576-cea4c106d62a
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