American Regent Inc. – FDA 483, Jun 18, 2026
American Regent Inc. in Hilliard, OH, was inspected from June 9-18, 2026, and received one observation. The inspection revealed that the firm's quality control unit failed to consistently follow its own procedures for managing quality events, specifically regarding the identification and implementation of Corrective and Preventive Actions (CAPAs) or providing justification when no CAPAs were deemed necessary. This deficiency led to instances of unauthorized raw material release and recurring visible particulate issues without adequate resolution.
ID · 96774b9a-8a5e-43f5-b5d5-7ecb941955b0
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