Goodwin Biotechnology, Inc. – FDA 483, May 16, 2025

Goodwin Biotechnology Inc. in Plantation, FL, was cited for significant deficiencies across its drug substance intermediate manufacturing operations. The inspection revealed widespread issues including inadequate contamination controls, unsanitary facility conditions, compromised data integrity in computerized systems and production records, and a lack of proper laboratory and quality unit oversight. These findings indicate a systemic failure to adhere to cGMP requirements.