FDA 483 - Goodwin Biotechnology, Inc. - April 10, 2019

Goodwin Biotechnology, Inc., a drug contract manufacturing and laboratory in Plantation, FL, was inspected by the FDA. The inspection revealed significant deficiencies in laboratory controls, including issues with method validation, bioburden testing, and sterility testing. Additionally, the firm failed to thoroughly review unexplained discrepancies and exhibited inadequate quality control unit procedures, impacting various aspects from SOP revisions to visual inspection and data integrity.