Cardiomedics quality audits, design controls spur letter.

Cardiomedics, an Irvine, CA, maker of external counterpulsation devices, was knocked in an April 13 letter for failure to implement a quality system that defined the quality practices, resources and activities relevant to manufactured devices, and for failure to implement design controls.

FDA said non-conformances were not documented in device history records, that corrective/preventive action procedures did not address investigations of causes of non-conforming products and that a formally-designated complaint- handling unit had not been established.

A laundry list of deficiencies was spelled out in the five-page letter, including: quality audits that did not verify the effectiveness of the quality system and, where necessary, reaudits that did not ensure corrective actions were undertaken; failure of appropriate management representatives to review these audit reports; absence of documented evidence to support validation of a design change made to the device; improperly validated system software; and inappropriate procedures for implementing corrective and preventive actions.

Additionally, the agency expressed "serious concerns" regarding Cardiomedics' 510(k) submission because the firm's declaration of conformity indicated compliance with design control requirements. However, investigators during the March 7-16 inspection were not able to reconcile design control activities undertaken by the firm.

Cardiomedics' March 21 response to the 483 did not "describe any corrective measures undertaken to ensure compliance" with the Quality Systems regulation and only indicated the company "is currently evaluating the observations and implementing a correction action plan to address the problems noted during our inspection."

In an interview, William Schilt, President-CEO of Cardiomedics, said that on May 9, "the company presented its corrective action plan to the FDA and is currently resolving all FDA observations." Schilt said the firm continues to manufacture its CardiAssist external counterpulsation systems.

"The FDA's observations are opportunities for us to improve our quality system and we expect to complete the improvements shortly," Schilt said. "In the meantime, we have confidence in our product and its effectiveness for the patient.

"The company is working closely with FDA, and with a focused sense of urgency, to resolve all issues raised as a result of the FDA inspection. We are implementing action plans to address FDA's observations and to prepare for re-inspection. We are totally confident we can correct all observations and believe that, based on current information, there will be no disruption in our ability to continue to supply product," Schilt said. Doc. 10267W