Supplier-Agreement Failures Result in FDA Warning

X Spine Systems’ failure to correct quality problems, document complaint assessments and establish quality requirements for suppliers was cited in a warning letter.

When the FDA inspected the firm’s Miamisburg, OH, facility April 7–18, it found several GMP violations. The company responded in May, but the agency sent a warning letter July 15, listing a dozen alleged failures X Spine must address.

The FDA cited the firm for revising a package insert for its Spider Cervical Plating System last September without notifying customers that a previous insert would not guarantee a specified sterility assurance level.

Although X Spine responded that a “field advisory notice” would be sent immediately to customers with unimplanted devices to assure they followed the current package insert, the agency says this response is not adequate. “It does not address how you will assure that the appropriate corrective and preventive action will be taken when a nonconformance is identified in the future,” the warning letter says.

The agency also cited the company for failing to establish quality requirements for suppliers and for not having supplier agreements requiring notification of design or manufacturing changes that might affect products.

X Spine replied that it had sent questionnaires and agreements by June 30 to Level I suppliers of implantable devices and revised its supplier-approval procedure to include quality requirements. The agency asks the company to provide copies of the questionnaire, new agreement and the revised approval procedure.

SOURCE: FDANEWS