Last month Integra LifeSciences initiated a global recall and production hold of all products manufactured at the company’s facility in Boston, MA. So it’s no surprise that the FDA has now hit the company with a warning letter addressing several violations at the plant.
However, the notice requirement raises questions about the company’s projected timeline for resuming sales of its tissue products.
The FDA inspected the company’s facilities in Boston, MA from March 1 through May 17, and issued the company Form 483 at the end of the inspection listing all inspection observations that needed to be addressed. Integra responded to Form 483 on June 8, but the FDA found some companies’ responses to be lacking.
The FDA warning letter notes that Integra failed to establish and maintain procedures to control products that do not conform to specified requirements. For example, in June 2019 Integra released many Durepair which contain high levels of endotoxin. The second breach noted that Integra failed to establish and maintain procedures for implementing corrective and preventive action (CAPA), including requirements to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products, and others. source of quality data to identify causes of existing and potential product nonconformities, or other quality problems.
According to the FDA warning letter, during the inspection, Integra initiated a health hazard evaluation (HHE) to address endotoxin issues and potential health risks. This evaluation, completed April 12, is not comprehensive and does not cover all complaints that may be related to the problem, according to the FDA. For example, two meningitis complaints related to Durepair Integra products were not included in the HHE assessment concluding that field action is not recommended.
“We understand that you have taken a series of corrective actions, including recalls and suspension of production, but your response does not indicate how you will prevent those errors from recurring while you resume operations,” the FDA wrote in the warning letter.
The warning letter also states that Integra failed to perform validation with a high level of assurance, a process whose results cannot be fully verified through subsequent inspection and testing. Specifically, the company failed to sufficiently validate its test methods to test bacterial endotoxins from finished medical devices.
“We need to review this CAPA to ensure it is comprehensive and will be effective in preventing similar failures from recurring as you continue distribution,” the FDA said in the warning letter, adding that Integra needed to provide evidence that it had reviewed all of its requirements. operations to ensure that the facility has validated processes in place.
Lastly, the warning letter notes the company’s failure to stock the device in a way to facilitate proper stock rotation and to properly assess its condition. On March 2, FDA investigators observed multiple implants that were sterile on unsecured open shelves located in a QC quarantine area and labeled as “non-sterile.” The FDA says the company’s procedures do not adequately prevent mix-ups of sterile/non-sterile materials.
The FDA noted that Integra received a complaint on October 20, 2022, which describes an instance where non-sterile products were handled in the same area as sterile products. According to the agency, CAPA was not started at that time to address this problem and to prevent its recurrence.
The warning letter obliges Integra to correct some of the violations and certify the outside consultant’s findings by the end of March 2024, with additional observations and certifications by the end of March 2025, and March 2026.
“Given these requirements, we wondered whether [Integra LifeSciences’] network sales may still continue below the previous timeline,” Ryan Zimmerman, a medtech analyst at BTIG, noted in a report Wednesday.
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