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FDA Sends Warning Letter To Integra Following Recall Of Surgical Repair Products

 
• By Brian Bossetta

After an inspection of its Boston facility, the US FDA issued a warning letter to Integra LifeSciences' subsidiary TEI Biosciences for distributing collagen-based medical devices that failed bacterial endotoxin tests and did not conform to good manufacturing practices.

Vintage inscription made by old typewriter, warning
• Source: Shutterstock

In a warning letter dated 17 July and posted online this week, the US Food and Drug Administration admonished TEI Biosciences, a subsidiary of Integra LifeSciences, over its handling of several products used for wound care, soft tissue repair and reconstruction surgery, including Durepair.

In the letter, which the FDA posted on 15 August, investigators said the company’s devices were “adulterated” and “not in conformity with the current good manufacturing

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