St. Jude used unsupported processes in catheter manufacturing, FDA says.(Medical Devices)

April 17--Minneapolis District

A Dec. 8-19 inspection of St. Jude Medical's Atrial Fibrillation Division in St. Paul, MN, found the ablation catheter manufacturer was not in conformity with GMPs.

FDAers cited the company for failure to adequately validate and approve, according to established procedures, processes whose results cannot be fully verified by subsequent inspection and test. A process was not validated for the Safire ablation catheter, and there was no documentation to establish equivalence between other similar products and processes that had been validated.

St. Jude also neglected to ensure that inspection and test equipment was suitable for its intended purposes or capable of producing valid results. For example, the Electrical Tester validation did not demonstrate that the electrical testing system was capable of consistently and accurately identifying problems with catheter wires.

There was no procedure in place for conducting CAPA risk assessments, FDA wrote. The company's CAPA procedure referenced a Risk Assessment procedure that had not been established.

St. Jude also failed to follow procedures for the control of products that did not conform to specifications. For example, materials that failed to meet the specified requirements of acceptance tests were not identified as non-conforming materials.

The company failed to document acceptance activities, the letter stated, noting that results of acceptance tests conducted as part of the Safire Ablation Catheter assembly were not fully documented on Shop Floor Paperwork (SFP). There was no documented review of the statistical rationale for the sample size of tests conducted, according to the manufacturing procedure for the MT OPS Safire Catheter Assembly.

St. Jude failed to follow procedures for controlling environmental conditions, the warning letter continued. Specifically, two employees on the Safire Ablation Catheter production line, located in a controlled environment, had the finger tips of their gloves removed and had direct skin contact with the product. Company procedures stated that gloves were to be worn at all times in controlled environment areas unless there is a safety concern for moving parts; however, there was no documentation that identified these locations.

FDA noted St. Jude promised corrective actions, "but several of the corrective actions have not been completed." With the exception of two issues, the agency wrote, "follow-up inspection will be required to assure that corrections are adequate." CAPA; QC/QS; Val

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