Mr. Jan De Witte
President and CEO
Integra LifeSciences Corporation
1100 Campus Road
Princeton , NJ 08540
United States
jan.dewitte@integralife.comFEI 3014334038Issued Jul 17, 2023Division of Medical Device and Radiological Health Division I
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3014334038.
Violations4
Issue DateJul 17, 2023
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Integra LifeSciences Corporation
Location
Mr. Jan De Witte
President and CEO
Integra LifeSciences Corporation
1100 Campus Road
Princeton , NJ 08540
United States
jan.dewitte@integralife.com
FEI Number
3014334038
Country
United States
Issue Date
July 17, 2023
Issuing Office
Division of Medical Device and Radiological Health Division I
Product Type
Medical Devices
Status
Open
Summary
Integra LifeSciences Corporation's subsidiary TEI Biosciences, a manufacturer of collagen-based wound care and soft tissue repair devices including the product Durepair, was cited for failing to comply with current good manufacturing practice (cGMP) requirements under the Quality System Regulation (21 CFR Part 820). The FDA inspection from March through May 2023 determined the devices were adulterated due to non-conforming manufacturing methods, facilities, and controls. In response, the company initiated a recall of all finished goods manufactured between March 1, 2018 and May 22, 2023, and committed to halting distribution until the facility achieved substantial compliance with quality system regulations.
Integra LifeSciences Corporation FDA Warning Letter, July 17, 2023
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