Integra LifeSciences Unit Receives FDA Quality System Warning Letter

MT Newswires Live
2025/01/07

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.

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10