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Integra LifeSciences Subsidiary Faces FDA Scrutiny Over Quality System Issues

AInvestMonday, Jan 6, 2025 9:21 am ET
2min read



Integra LifeSciences, a leading provider of regenerative tissue technologies and orthopedic devices, is facing scrutiny from the U.S. Food and Drug Administration (FDA) following a warning letter issued in July 2023. The letter, addressed to TEI Biosciences, an Integra LifeSciences subsidiary, highlights several quality system issues that have led to a voluntary recall of products and a production hold at the Boston-based manufacturing facility.

The FDA inspection, conducted between March 1 and May 17, 2023, revealed that the collagen-based medical devices manufactured at the Boston facility were adulterated, as they did not meet the current good manufacturing practice requirements of the Quality System regulation (21 CFR Part 820). The warning letter outlines several violations, including:

1. Failure to establish and maintain procedures to control product that does not conform to specified requirements, leading to the release of a lot of Durepair with an out-of-specification bacterial endotoxin (BET) result.
2. Failure to establish and maintain procedures for implementing corrective and preventive actions, resulting in inadequate responses to internal complaints and endotoxin concerns.
3. Co-mingling of sterilized medical devices and non-sterile products within the same workspace, posing a risk of cross-contamination and compromising product sterility.

In response to the warning letter, Integra LifeSciences has taken several corrective actions, including:

1. Initiating a voluntary recall of all products manufactured at the Boston facility between March 2018 and May 2023, affecting SurgiMend, PriMatrix, Revize, and TissueMend products.
2. Pausing manufacturing at the facility until it can implement additional quality controls and address the FDA's concerns.
3. Opening corrective and preventive action (CAPA) plans to address nonconformance deficiencies and endotoxin issues.
4. Addressing specific issues, such as bacterial endotoxin testing and the separation of sterilized and non-sterile products.

However, the FDA remains concerned about the effectiveness of Integra LifeSciences' quality management system and the potential for similar errors to occur when manufacturing resumes. The company must now provide evidence of an effective and sustainable corrective and preventive action system to prevent future errors and ensure product quality.



The quality system issues at Integra LifeSciences' Boston facility have had a significant impact on the company's reputation and customer trust. The voluntary recall and production hold are expected to result in an impairment charge of $22 million on the company's second-quarter earnings and a reduction of $60 million in full-year earnings if the hold continues through the end of the year. The FDA's warning letter may further erode customer trust and impact the company's stock price, which has been volatile since the recall announcement in May 2023.

In conclusion, Integra LifeSciences is facing a challenging situation following the FDA's warning letter to its subsidiary, TEI Biosciences. The company must address the quality system issues promptly and effectively to restore customer trust, prevent future occurrences, and avoid further regulatory actions. Investors should closely monitor the situation and assess the potential impact on the company's financial performance and stock price.
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