FDA EIR - PENTAPHARM AG - September 15, 2016

An FDA inspection of DSM Nutritional Products Ltd Branch Pentapharm, a manufacturer of Class II In Vitro Diagnostic Kits and pharmaceutical products, was conducted from September 12-15, 2016. This routine inspection, guided by the Compliance Program 7282.845 for Medical Device Manufacturers, assessed Management Controls, Design, Corrective and Preventive Action (CAPA), and Production and Process Controls. The primary violation, documented on an FDA Form 483, concerned inadequate procedures for corrective and preventive action, specifically non-compliance with 21 CFR 820.100(a). The firm's CAPA procedure did not adequately ensure that all quality data sources were analyzed to identify potential quality issues, and actions taken to improve the CAPA system, including retrospective reviews of past CAPAs for effectiveness, were not properly documented within a CAPA. Beyond this formal observation, other issues discussed with management included an inadequate frequency of internal audits, undefined management review attendees, deficiencies in complaint investigations, and insufficient change control records. Concerns were also raised regarding the utilization of supplier data, where critical suppliers were not consistently identified, and validation documents for reagents from 2003-2004 remained unsigned until prompted during the inspection. The company committed to correcting all identified issues.