Validation Failures Plague Italian Devicemaker Gallini

April 27, 2018

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, and batch records for test batches.”

The firm that makes surgical equipment had not established adequate CAPA procedures, the agency said. In one example, actions were taken in response to a complaint on March 30, 2016, but a CAPA was not initiated until Nov. 14, 2016.

The FDA determined that process control procedures were lacking, and the firm failed to establish adequate procedures to control nonconforming products.

The FDA said the firm did not properly evaluate design changes to be sure changes didn’t adversely affect the safety, efficacy or performance specification of products.

Read the Gallini Form 483 here: www.fdanews.com/04-25-18-galinisrl483.pdf.