Zimmer Biomet received a warning letter from the FDA Aug. 24 concerning its Warsaw, Ind.-based North Campus manufacturing facility, according to Street Insider.
Here are six things to know:
1. The FDA previously inspected the Zimmer Biomet's Warsaw North Campus in 2016 and issued a Form 483 with inspection observations and conclusions. The FDA then conducted a re-inspection in April and issued a second Form 483. The Aug. 24 warning letter outlines the steps Zimmer Biomet has taken to address the FDA's concerns, but it also notes violations that require action or explanation.
2. Zimmer Biomet previously provided the FDA with a written response to corrective actions and plans to provide regular updates on its quality remediation plan at the plant. The company will also respond to the most recent warning letter within 15 days and expects to schedule a proposed regulatory meeting after the response to the most recent letter is submitted.
3. The warning letter didn't restrict production or shipment of products from the facility. The company is also able to keep products from the plant on the market place and can continue to seek FDA 510(k) clearances for its products.
4. However, the warning letter does state that certificates to foreign government requests will not be granted before the violations are corrected, and it won't grant premarket approvals for Class III devices for applications related to the quality system regulation violations.
5. The company believes all concerns in the warning letter "can be resolved without material impact" to its financial results. "We cannot, however, give any assurances that the FDA will be satisfied with our response to the warning letter or as to the expected date of the resolution of the matters included in the warning letter."
6. The FDA could take additional regulatory action that would potentially restrict manufacturing, marketing and selling products in the future until issues cited in the warning letter are resolved.
During its second quarter conference call, Zimmer Biomet CEO Bryan Hanson addressed the FDA's 483 observations from its re-inspection in April. At the time, the facility continued to manufacture its full range of products. "At Zimmer Biomet, patient safety is our first and guiding priority, completing our quality remediation to the highest standards is of utmost importance and we take it very seriously," he said. "However, fixing these issues in the right way takes time. I remain confident in the people and the processes we have in place and I can assure you that we will continue to appropriately resource and staff this important work and we will keep the FDA updated on our progress."