The FDA issued a warning letter to TEI Biosciences’ for “systemic” quality failures the agency found during an Oct. 9 to Nov. 2, 2018, inspection of its Boston, Mass., facility.
The facility makes collagen-based medical devices used for wound care, soft tissue repair and reconstruction surgery, including the Xenform Soft Tissue Repair Matrix.
Although the firm took additional corrective and preventive actions following the inspection, the agency was not satisfied. For example, the facility lacked data to show that the water system used to manufacture devices was free of bacterial endotoxins.
In addition, the FDA said the manufacturing process for TEI’s Xenform devices did not follow the firm’s validation protocol.