FDA 483 - COLONIAL DAMES CO LTD - April 29, 2021

An FDA inspection of Colonial Dames Company Ltd in Commerce, CA, revealed critical deficiencies in their drug product manufacturing and quality control systems. The firm failed to conduct required finished product testing before release, lacked essential written procedures for quality operations like change control and investigations, and assigned expiration dates without supporting stability data. These findings indicate a significant lack of adherence to good manufacturing practices.