Zimmer Biomet Receives FDA Warning Letter

• September 4, 2018
• FDA, Product Liability

On August 24, 2018, Zimmer Biomet received a Warning Letter from the FDA regarding quality violations found during 2016 and 2018 inspections at a facility in Warsaw, IN.

The FDA inspected Zimmer Biomet’s North Campus manufacturing facility in 2016, documenting a number of violations in Form 483. Although Zimmer Biomet responded about how it would address the issues, a re-inspection in April of this year resulted in another Form 483.

The August Warning Letter, triggered from the April re-inspection, cites “our recent inspection revealed continuing significant violations of the quality system regulations.”

FDA Concerns About Zimmer Biomet Violations

The Warning Letter addressed several of the violations Zimmer Biomet was cited for, including, but not limited to:

Failure to establish and maintain procedures for verifying or validating a corrective and preventive action.

“During the inspection, review of three separate CAPA’s revealed that your firm has not been able to demonstrate that the corrective or preventive actions taken by your firm are effective in ensuring that devices being distributed meet all finished product specifications. … We are concerned about your firm’s ability to verify the effectiveness of the corrective actions included in this CAPA, when errors are not being identified in your interim processes.”

Failure to develop, conduct, control and monitor production processes to ensure that a device confirms to its specifications, including the monitoring and control of process parameters and device characteristics during production.

“During the inspection, we observed five separate operations in which employees on the production line were not following production procedures adequately.”

All five of these obervations are addressed within the Warning Letter.

Problems were also found with the North Campus facility’s design validation processes, its handling of non-conformance reports and its CAPA implementation.

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Key Points to Note

• A Form 483 was issued to Zimmer Biomet after the FDA inspected the North Campus in 2016, which included inspection observations and conclusions. A re-inspection was conducted in April 2018 and a second Form 483 was issued.
• A Warning Letter was issued August 24, 2018 outlining the steps Zimmer Biomet has taken to address these concerns; however, it also notes violations that require action or explanation.
• The Warning Letter did not restrict production or shipment of products from the facility nor does it require Zimmer Biomet to pull any products from the market. It also does not affect the company’s ability to seek FDA 510(k) clearance for its devices.
• The Warning Letter prohibits the issuance of Certificates to Foreign Governments (FDA certification that the products made there are in compliance with FDA standards) until the deficiencies are corrected and it won’t grant premarket approvals for Class III devices for applications related to the quality system regulation violations.
• This letter is not intended to be an “all-inclusive list of the violations” at the Zimmer Biomet facility.

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