Devices

FDA Warns MAST Biosurgery Over Manufacturing Violations

FDA has issued MAST Biosurgery USA a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting violations related to the company’s SurgiWrap FROST surgical mesh products. The 12/17 letter says the inspection found that the products were adulterated under federal law because the company failed to comply with Quality System Regulation requirements governing medical device manufacturing.

According to the agency, MAST did not implement adequate procedures to prevent contamination of its implantable surgical mesh devices, including failing to conduct endotoxin testing prior to product release. FDA said the company had committed during premarket review to test SurgiWrap FROST for endotoxins to ensure levels remained at or below the FDA-accepted limit of 20 endotoxin units per device, but did not implement such testing before distributing the product beginning in 2021.

The agency said the company only established an endotoxin specification in 8/2024, years after commercialization, and failed to provide sufficient scientific justification for its acceptance criteria. FDA reviewers also cited evidence of rising endotoxin levels in more recent production lots and instructed the company not to relax monitoring standards or increase acceptance thresholds.

The letter also identified deficiencies in MAST’s complaint handling system. FDA investigators found that the company categorized certain customer complaints as “feedback,” allowing them to be closed without proper investigation or documentation. In one cited case, a complaint alleging abdominal swelling in eight out of 10 patients following use of SurgiWrap was closed without a documented investigation after being reclassified as feedback.

Additionally, the agency found violations of Medical Device Reporting (MDR) requirements, stating that MAST failed to submit mandatory reports for serious injuries associated with SurgiWrap devices within the required 30-day timeframe. FDA cited cases involving postoperative ileus and small intestinal stenosis that required medical or surgical intervention, which meet the regulatory definition of reportable serious injuries.

Although the company referenced MDR submissions in its internal records, the agency said it never received the reports. The agency rejected the company’s internal risk assessment that the events were not reportable, noting that physicians had identified a causal relationship between the device and the injuries, according to the letter.

FDA said it will conduct a follow-up inspection to verify whether corrective actions are adequate and warned that failure to promptly address the violations could result in enforcement actions, including product seizure, injunction, or civil monetary penalties.

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