The FDA says Integra Lifesciences
(Nasdaq: IART)
has inadequately responded to violations that it found at the company’s TEI Biosciences plant in Boston.
Integra Lifesciences’ Boston facility makes extracellular bovine matrix products for tissue repair and regeneration, wound care and more. In May, the company voluntarily recalled all tissue-related products made in Boston and distributed between March 1, 2018 and May 22, 2023. The recalled products included SurgiMend, PriMatrix, Revize and TissueMend. According to the company, an internal investigation found deviations with endotoxin testing. The result was a release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, including a postoperative fever.
The facility previously received an FDA warning letter in 2019. A new FDA warning letter — dated July 17 and posted on FDA’s website on Aug. 15 — is based on a new inspection from March 1 through May 17. It notes the recall as well as a company response dated June 8.
The new letter lists four violations:
- Not conforming to procedures to control product;
- Failure to establish and maintain procedures for implementing corrective and preventive actions;
- Failure to validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test;
- Failure to store devices in a manner to facilitate proper stock rotation and to assess its condition as appropriate.
On all four counts, the FDA says Integra Lifesciences’ response has not been adequate. (Read the full warning letter here.)
Integra Lifesciences says it takes the FDA’s concerns seriously
In a statement shared with MassDevice, the company said it takes commitment to patient safety and product quality very seriously. The company is working closely with the FDA to fully address its concerns related to the Boston facility.
Integra Lifesciences added: “We will not resume production until we have addressed the FDA concerns and are confident the facility meets the strictest regulatory and product quality standards, which we anticipate will occur by the end of the calendar year.”
The FDA warning letter says Integra Lifesciences has until March 31, 2024, to provide initial certification by an outside consultant, with subsequent certifications provided March 31, 2025, and March 31, 2026.
