483
American Regent Inc.FDA 483 - American Regent Inc. - July 20, 2023
Record Details
American Regent Inc. in Hilliard, OH, a manufacturer of sterile drugs, was inspected by the FDA from July 10-20, 2023. The inspection revealed significant deficiencies in production and process control procedures, as well as failures within the quality control unit. These issues indicate a lack of adherence to good manufacturing practices and proper documentation.
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ID · 1b739e8a-3e1f-409e-94ce-877349179bc0