Integra LifeSciences Holdings Corporation announced that a subsidiary received a Warning Letter from the U.S. Food and Drug Administration (FDA). The letter addresses quality system issues identified during FDA inspections conducted in June and August 2024 at three of the company's facilities located in Massachusetts and New Jersey.
The FDA Warning Letter specifies that premarket approval applications (PMAs) for Class III devices related to these quality system violations will not be approved until the issues are corrected. However, the letter does not restrict the company's ability to manufacture or ship existing products, nor does it prevent seeking 510(k) clearance for other products.
Integra LifeSciences had previously submitted responses to the observations from the June and August inspections and is preparing a written response to the Warning Letter. The company stated it is not aware of additional actions stemming from the letter that would materially impact its previously announced operational or financial expectations, and it reaffirmed its fourth-quarter revenue guidance.
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