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FDA issues warning letter to Zimmer Biomet for North Campus manufacturing facility
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On Aug. 24, 2018, the FDA issued a warning letter to a subsidiary of Zimmer Biomet Holdings Inc. related to non-conformities to current good manufacturing practice requirements of the quality system regulation at a manufacturing facility in Warsaw, Indiana.
According to the Zimmer Biomet Holdings’ Aug. 24 U.S. Securities and Exchange Commission form 8-K filing, the warning letter is specific to the Warsaw North Campus facility, which underwent inspections by the FDA, first in 2016 and then again in April 2018, both of which resulted in the FDA issuing a Form 483 with inspectional observations.
In its SEC filing, the company stated, “We have provided written responses to the FDA detailing corrective actions underway to address the FDA’s observations and have provided, and will continue to provide, regular updates to the FDA regarding our quality remediation plan at the Warsaw North Campus.”
Concerns from FDA
According to the warning letter, the FDA noted Zimmer Biomet:
- failed to establish and maintain procedures for verifying or validating the corrective and preventive action to ensure that the action is effective and does not adversely affect the finished device;
- failed to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure;
- failed 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;
- failed to establish and maintain design validation procedures to ensure proper risk analysis is completed;
- failed to establish and maintain procedures to adequately control environmental conditions when these could reasonably be expected to have an adverse effect on product quality; and
- failed to establish and maintain procedures for implementing corrective and preventive actions, including requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems.
The warning letter acknowledges the quality remediation plan, as well as actions already taken by Zimmer Biomet to address the FDA’s inspectional observations.
Zimmer Biomet noted in its SEC filing that it addressed violations that required additional action or explanation. The FDA also proposed a regulatory meeting be held to discuss the proposed corrections with Zimmer Biomet.
“We expect that the proposed regulatory meeting will take place subsequent to the submission of our written response to the warning letter,” Zimmer Biomet wrote in its form 8-K document.
Current restrictions
The company noted the warning letter does not restrict production or shipment of products from the Warsaw North Campus facility or require withdrawal of any product from the marketplace nor does it restrict requests for FDA 510(k) clearance of products. However, Zimmer Biomet acknowledges that certificates to foreign governments will not be granted and premarket approval applications for class III devices will not be approved until the violations have been corrected.
Zimmer Biomet also stated in its filing it believes concerns listed in the warning letter can be resolved without a material impact to its financial results.
“Until the issues cited in the warning letter are resolved to the FDA’s satisfaction, the FDA may initiate additional regulatory action without further notice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively manufacturing, marketing and selling our products and could have a material adverse effect on our business, financial condition and results of operations,” Zimmer Biomet wrote.
Zimmer Biomet is in the process of preparing a written response to the warning letter, according to the SEC document.
References:
Zimmer Biomet U.S. SEC FORM 8-K filing, Aug. 24, 2018: otp.investis.com/clients/us/zimmer_biomet/SEC/sec-show.aspx?Type=page&FilingId=12935284-3941-9736&CIK=0001136869&Index=11000; Accessed: Sept. 6, 2018.
FDA warning letter: www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm618429.htm; Accessed: Sept. 6, 2018.