FDA EIR - DDL, Inc. - October 01, 2020

An FDA Pre-Approval Inspection of DDL Inc., a laboratory conducting physical testing of drug products in Irvine, CA, was conducted from September 30 to October 1, 2020. The inspection, performed under CPGM 7346.832 for Pre-Approval Inspections, focused on the firm's quality and laboratory systems for drug product release and stability testing. DDL Inc. is subject to the FD&C Act due to its role in testing these products. A significant issue documented in an FDA Form 483 was the inadequate control over electronic records, specifically within the (b) (4) software system used for critical testing. This violation, citing 21 CFR 211.194(b), highlighted the absence of individual user logins, the assignment of (b) (4) authorities to all users, and a complete lack of audit trail capabilities to track or review changes. Management initiated corrective action requests concerning these computer system deficiencies. Discussions during the inspection also revealed that DDL Inc. was not aware of the specific commodity of the products it tested, which impacts regulatory adherence. Furthermore, testing procedures for certain drug products did not align with their intended use, as they omitted a required warm-up period specified in the prescribing information and relevant ISO standards. The company was advised to address these procedural gaps, ensure appropriate product knowledge, and consider FDA registration.