Validation Failures Plague Italian Devicemaker

Numerous validation issues and CAPA failures were uncovered during a 2017 inspection of Gallini’s Mirandola, Italy manufacturing plant.

Validation failures cited in the Form 483 included inadequate test validation and process validation procedures and an inadequate validation master plan.

The FDA inspector pointed to missing critical parameters for testing, failure to indicate sample sizes or to select random samples, and missing packaging validation procedures.

FDA investigators found “no protocols, sample size rationale, worst product/package evaluation operational qualification, performance qualification, [or] batch records for test batches.”