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

An FDA inspection of DDP Specialty Electronic Materials US 9, LLC, an Active Pharmaceutical Ingredient (API) manufacturer in Hemlock, MI, occurred from November 5-7, 2018. This routine Good Manufacturing Practice (GMP) inspection was conducted under Compliance Program 7356.002F. The company, formerly known as Dow Corning Corporation, specializes in manufacturing non-sterile APIs, including Simethicone products. The inspection resulted in one significant observation documented on an FDA Form 483. The primary issue was that original laboratory records, specifically electronic raw data from analytical instruments, were not thoroughly reviewed for accuracy, completeness, or compliance with established standards. Inspectors noted that only printouts were reviewed, and the crucial audit trail function was neither enabled nor evaluated. This practice impacts data integrity, which is essential for ensuring product quality. Furthermore, four critical discussion items were formally communicated to management. These included inadequacies in documenting corrective and preventive actions for raw material deviations, a lack of clear protocols for conducting risk assessments related to identified microorganisms beyond standard limits, and an unapproved decision to discontinue the visual inspection of retain samples. This change was implemented in 2017 but only formally initiated for change control in July 2018. Management indicated they would provide a written response to the FDA 483 within 15 business days. Required actions, based on the findings, include developing and implementing robust procedures for reviewing electronic raw data and audit trails, strengthening deviation investigation processes, clarifying microbial risk assessment protocols, and ensuring all procedural changes are formally approved before implementation.