FDA 483 - COLONIAL DAMES CO LTD - April 12, 2023

An FDA inspection of COLONIAL DAMES CO LTD in Commerce, CA, revealed significant deficiencies in their manufacturing practices for drug products. The firm failed to implement adequate cleaning validation, qualify its water system, investigate out-of-specification results, and establish proper quality agreements. Additionally, the company lacked annual product reviews and a written stability testing program, indicating a broad failure to adhere to cGMP regulations.