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

During an inspection conducted by the Food and Drug Administration (FDA) from November 5-7, 2018, DDP Specialty Electronic Materials U.S. 9, LLC, an Active Pharmaceutical Ingredient (API) manufacturer in Hemlock, MI, received an FDA Form 483. The inspection identified a significant observation concerning the integrity and review of laboratory data. Specifically, the firm was cited for not adequately reviewing original records for accuracy, completeness, and compliance with established standards. The quality review process for raw data from laboratory testing, such as FT-IR data, was found to be insufficient, as it only included review of printed outputs and not the electronic raw data itself. This electronic data is crucial for determining the quality attributes of products like Q7-2243 LVA, Simethicone USP, and Q7-2587, 30% Simethicone Emulsion USP. Furthermore, the audit trail function for this critical data was neither enabled nor reviewed, which raises concerns about data traceability and security. This observation suggests a lack of robust data governance practices essential for ensuring product quality and and patient safety, as required under FDA regulations. DDP Specialty Electronic Materials U.S. 9, LLC is now required to address these inspectional findings by evaluating the observations, discussing any objections, and implementing appropriate corrective and preventive actions to ensure full compliance with regulatory requirements.