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www.fdanews.com/articles/10076-ansm-inspections-reveal-validation-qualification-shortcomings

ANSM Inspections Reveal Validation, Qualification Shortcomings

June 3, 2016

Inspections conducted by France’s ANSM of makers of implantable defibrillation leads found qualification and validation processes were the largest compliance problems.

Between November 2013 and June 2014 the agency conducted audits at six sites for St. Jude Medical, Medtronic, Boston Scientific and Sorin. German manufacturer Biotronik refused to be inspected.

Findings revealed manufacturers generally met EC marking requirements.

The areas identified for improvement were:

  • Qualification plans for each site and sterilization chamber;
  • Validation of ethylene oxide re-sterilization on the device performance and the packaging strength;
  • Validation of sterilization processes; and
  • Qualification of controlled atmosphere areas.

In terms of risk analysis, major deviations encountered were:

  • Lack of complete risk analysis plans;
  • Inefficient approaches to risk-benefit analysis and residual risk;
  • Batch release management by the production unit; and
  • Lack of qualified management staff with documented assigned responsibilities.

The agency noted that an injunction was issued to one devicemaker for two of its sites in Minnesota and Puerto Rico for failure to demonstrate biocompatibility of products and gaps in validation processes.

Read the inspection report here: www.fdanews.com/05-26-16-ANSMInspectionReport.pdf. — Joya Patel