483
Fagron, IncFagron, Inc – FDA 483, Apr 10, 2019
Record Details
An FDA inspection of Fagron, Inc. in Saint Paul, MN, a manufacturer and repackager, revealed two significant observations related to quality control. The firm was cited for not having written responsibilities and procedures for its quality control unit, and for lacking a final approval process for Certificates of Analysis accompanying repackaged and distributed products. These findings indicate deficiencies in the firm's quality management system.
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ID · bc7dab8a-7f35-47e7-b45f-003601bd5f9c
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