483
American Regent, Inc.FDA 483 - American Regent, Inc. - September 30, 2022
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Record Details
American Regent, Inc. in New Albany, OH, a sterile drug manufacturer, was cited for deficiencies within its quality control unit. The firm failed to fully follow its responsibilities and procedures, including making modifications to a visual inspection booth without change control. Additionally, the company did not investigate HEPA recertification failures and had multiple documentation errors in quality records.
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