07:56 AM EST, 01/07/2025 (MT Newswires) -- Integra LifeSciences ( IART ) said in a regulatory filing Tuesday that one of its subsidiaries received a warning letter from the US Food and Drug Administration related to quality system issues.

The company said the issues were found during FDA inspections at three facilities in Mansfield, Massachusetts; Plainsboro, New Jersey, and Princeton, New Jersey.

Integra said the letter did not identify any new issues that had not already been provided in the Form 483s that had already been sent to the company following three FDA inspections in June and August. The forms are used by the FDA to record potential violations during an inspection.

The company said that in the Form 483s, the FDA found that certain devices, including cranial perforators, disposable cottonoid patties, strips, and collagen-based products, were out of compliance with quality system regulations.

Integra added that the warning letter does not restrict it from manufacturing or shipping products, and does not require a recall of any of its products.