483
Harmac Medical Products, Inc.FDA 483 - Harmac Medical Products, Inc. - December 12, 2019
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An FDA inspection of Harmac Medical Products, Inc., a medical device contract manufacturer in Buffalo, NY, identified one significant observation. The firm's procedures for corrective and preventive action were found to be inadequately established, with several CAPAs lacking proper verification or validation of effectiveness. This indicates a moderate compliance issue related to quality system controls.
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ID · ea9364e8-b7b3-45d4-aaaa-5e6b29879560