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.

In addition, Zimmer did not have adequate procedures for corrective and preventive actions. For example, one of its procedures did not establish requirements for analyzing data sources. The corrective actions did not prevent quality issues from recurring, and there were no established procedures for investigating the cause of nonconformities.

The inspectors also reported inadequate process control procedures. For example, packaging operations were not adequately controlled.

The FDA’s Quality System Regulation requires devicemakers to develop and maintain four files of information related to design, production and overall quality system. Order Device Documentation for a detailed guide that will help you understand each element and their relationships with each other, as well as guidance on how to develop the files.