FDA warning letter details quality concerns, violations at Integra facility
Medical device manufacturer Integra LifeSciences has received a warning letter from the U.S. Food and Drug Administration (FDA) due to multiple quality issues. The agency first issued the message back in in July, but it was posted on the FDA's website on August 15.
The warning letter centers on an assortment of quality-related issues discovered at Integra's facility in Boston. This facility is responsible for producing cutting-edge collagen-based medical devices primarily used in wound care, soft tissue repair and complex reconstruction surgeries.
At the core of the FDA's complaint is Integra’s apparent failure to promptly address and rectify problems as they emerged. As a cited example, Integra allegedly continued the co-mingling of sterilized medical devices and non-sterile products within the same workspace, despite knowledge of the safety risks.
Of particular note in the warning was the handling of Durepair, a critical collagen matrix integral to neurosurgical procedures, manufactured by Integra for industry leader Medtronic. According to the letter, Integra released a batch of Durepair in 2019 that exceeded permissible limits for bacterial endotoxin – a factor known to trigger postoperative fever. Integra attributed this error to a transcription mistake, which the FDA deemed inadequate as a justification.
The issues intensified when Integra, reacting to an internal complaint about quality concerns in December 2022, temporarily halted production at the Boston facility. These concerns encompassed various aspects, including the inspection process, bacterial endotoxin testing, accuracy of bovine hide or skin thickness measurements, and oversight of sterilized devices. It was concerning that Integra's initial corrective plan did not adequately address the endotoxin problems, according to the FDA's evaluation.
During a subsequent inspection conducted by the FDA earlier this year, Integra initiated a health hazard assessment to tackle the endotoxin worries. However, the agency found this evaluation to be insufficient, highlighting the omission of two cases of meningitis linked to the use of Durepair.
While acknowledging Integra's subsequent corrective actions, including product recalls and production halts, the letter raised concerns about the prevention of future recurrence of such errors once manufacturing resumes. The FDA has demanded concrete evidence of an effective and enduring corrective and preventive action system to be implemented by the company, demanding Integra to rectify numerous issues and validate an external consultant's findings by March 31, 2024. Subsequent observations and certifications are also mandated for 2025 and 2026.
The warning comes after Integra announced a voluntary recall in May of all products manufactured in its Boston facility between March 2018 and May 2023.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.