FDA 483 - DDP Specialty Electronic Materials US 9, LLC - November 07, 2018

An FDA inspection of DDP Specialty Electronic Materials U.S. 9, LLC in Hemlock, MI, an API manufacturer, revealed significant data integrity concerns. The firm failed to adequately review original laboratory records, including electronic raw data and audit trails, for accuracy and completeness. This deficiency impacts the quality determination of products like Simethicone USP.