Zimmer Biomet Acknowledges 11 Observations in Form 483

By Julie A. Vetalice

As noted by leadership in its 1Q18 earnings call, FDA performed an inspection of Zimmer Biomet's Warsaw North Campus manufacturing facility which concluded on April 24, 2018. FDA issued a Form 483 with 11 inspectional observations. None identified specific performance issues with any product, and all products continue to be manufactured in the facility.

The new Form 483 includes three new and eight repeating observations from the inspection conducted from September to November 2016. The 2016 inspection included 14 observations.

Latest observations address corrective actions to prevent recurrence of bacterial failures in polyethylene devices, sterilization cycle validation, risk analysis for sterile packaging, lack of documentation on test methods, procedures to control environmental conditions, inadequate training procedures, etc.

In the 1Q18 call, CEO Bryan Hanson noted that recovery in knee, hip and S.E.T. is on track with the goal to restore supply in substantially all key brands by the beginning of 3Q18.

Sources: Zimmer Biomet, Inc.; ORTHOWORLD Inc.



Tags: Regulatory