Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016.
In 14 observations — including 2 repeat observations first found in a 2014 inspection — the 483 listed numerous problems with validation of processes, inadequate environmental monitoring, water quality, product design, and other issues. The repeat observations were for inadequate validations and cleaning process monitoring.
The company’s standard operating procedures failed to ensure that nonconforming products were consistently documented and evaluated, the inspectors found. — Jeff Kinney