Harmac Medical Products, Inc.December 12, 2019

FDA 483 - Harmac Medical Products, Inc. - December 12, 2019

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Record Details

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.

Company: Harmac Medical Products, Inc.
Inspection Date: December 12, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Matthew D. Schnittker

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ID · ea9364e8-b7b3-45d4-aaaa-5e6b29879560