FDA 483 - American Regent, Inc. - January 29, 2026
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American Regent, Inc. in New Albany, OH, a sterile drug manufacturer, received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into batch failures, sterility issues, and out-of-specification results. Additionally, the firm failed to adequately manage supplier quality and adhere to aseptic manufacturing procedures, indicating a systemic breakdown in their quality management system.
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