Integra Lifesciences has been issued a warning letter by the FDA regarding quality control problems identified at multiple locations. The disclosure came through an SEC filing, where it was revealed that the letter, received on December 19, 2024, outlines deficiencies noted during FDA audits at three facilities located in Mansfield, Massachusetts, Plainsboro, New Jersey, and Princeton, New Jersey.
Previously, in August 2023, Integra Lifesciences faced a warning from the FDA following insufficient corrective actions at its TEI Biosciences plant in Boston. This recent notice reflects issues already highlighted in Form 483s from audits conducted in June and August of 2024, with no new findings.
Devices such as cranial perforators, single-use cottonoid patties, strips, as well as products derived from collagen, have been flagged as non-compliant with quality regulations. In response, Integra halted shipments of certain items and voluntary recalled the single-use patties and strips.
The FDA’s warning doesn’t restrict Integra’s manufacturing or distribution nor demand further recalls or affect product clearance under FDA 510(k). However, premarket approval for Class III devices tied to these quality issues remains pending until resolution.
The SEC filing notes that Integra has submitted multiple responses to the Form 483s and is drafting a comprehensive reply to the warning letter.
“Integra Lifesciences treats the concerns in the warning letter with the utmost seriousness, committed to collaborating with the FDA to address all issues while continuing to develop a robust compliance master plan,” the filing stated. Announced in July 2024, this plan aims at strengthening quality management processes across all operations.
Integra remains unaware of any further consequences of the warning letter that could significantly affect its operational or financial projections. They uphold their forecasted revenue for Q4, ranging from $441 million to $451 million.