EMD Millipore Corporation – FDA EIR, Oct 15, 2014

A routine abbreviated FDA inspection of EMD Millipore Corporation in Temecula, CA, was conducted from October 14-15, 2014. The inspection, focusing on Corrective and Preventive Actions (CAPA) and Production and Process Control, covered the company's manufacturing of Class I and Class II In Vitro Diagnostics (IVD). Key issues identified included incomplete training documentation for manufacturing employees regarding specific SOPs, an incomplete training Standard Operating Procedure (SOP) lacking details on validated processes, and an incomplete customer complaint SOP that did not address investigations when products were not returned. The inspection also noted an incomplete CAPA record that failed to reference related past issues, and a batch record discrepancy where an efficiency specification was used without being defined in the corresponding SOP. Management was advised on the need for clearer documentation and, in one instance, a second-scientist review for Out-of-Specification investigations. EMD Millipore Corporation cooperated fully, initiating prompt corrections during the inspection and committing to resolve all noted observations. No FDA-483, which lists inspectional observations, was issued at the close of the inspection, reflecting the firm's immediate and voluntary actions.