Response to FDA 483 Observations Issued to Zimmer Biomet, Warsaw North Campus, November 22, 2016

Introduction

Zimmer Biomet responds to FDA 483 observations issued on November 22, 2016, at their Warsaw North Campus facility.

Commitment to Compliance

Zimmer Biomet recognizes the significance of the FDA-483 observations and is committed to taking all necessary actions to ensure compliance with FDA requirements and product safety and effectiveness.

Remediation Efforts

The company has taken immediate actions to address quality culture issues, including corporate quality audits, remediation programs, and management changes.

These efforts aim to correct specific items listed in the FDA-483 and address systemic issues, such as design controls, sterile packaging, complaint handling, and nonconforming material.

Resource Commitment

Zimmer Biomet has approved significant funding for remediation efforts and has committed additional resources to support post-market surveillance and quality assurance.

Corrective Actions

The company has taken immediate actions during the inspection, including product ship holds, implementation of interim control documents, and modifications to final cleaning processes for metal products.

These actions demonstrate Zimmer Biomet’s commitment to addressing the issues identified by the FDA.

Manual:

Download: Response to FDA 483 Observations Issued to Zimmer Biomet, Warsaw North Campus, November 22, 2016