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FDA Issues Warning Letter to Medical Device Maker Edwards Lifesciences

Jun 17, 2013

The U.S. Food and Drug Administration (FDA) recently conducted a month-long inspection of the Edwards Lifesciences manufacturing facility in Draper, Utah. The inspection prompted two recalls and a detailed warning letter to investors.

The FDA cited seven manufacturing violations. Some of these, according to, resulted in recalls. Violations included the company’s "failure to validate" certain manufacturing processes that "cannot be fully verified by subsequent inspection and test." Six customer complaints were noted by the inspectors over Edwards’ QuickDraw cannulae that fractured during cardiac procedures. The inspectors noted that Edwards Lifesciences does not appropriately validate the temperatures of its ovens, which is needed to maintain appropriate manufacturing bonding, explained.

According to the FDA’s very detailed, lengthy letter, “the inspection revealed that these devices are adulterated… in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation.”

In a March 15 response, according to, Edwards Lifesciences stated that broken cannulae were the result of physician error, "in spite of the complaint investigations concluding the bonds were breaking due to inadequate oven temperatures," the FDA’s letter indicated. The company also later advised the agency that it had stopped manufacturing the QuickDraw cannulae and had initiated a global recall. Edwards recalled its ProPlege Peripheral Retrograde Cardioplegia device kits during the inspection, according to the FDA letter.

Concerning that, the FDA wrote that “[w]e have reviewed your March 15 and April 30 responses, and also acknowledge that you initiated a recall of the ProPlege Peripheral Retrograde Cardioplegia Device Kits (PR9) during the inspection. However, we cannot fully evaluate the adequacy of your response at this time because you did not provide any timeframes for the systemic corrective actions you indicated for your Design Verification and Design Validation activities, and these corrective actions will have to be evaluated once completed.”

The FDA also indicated in its letter—in more than one area—that, “We have reviewed your … responses … we cannot determine the adequacy of your corrective actions at this time.”

Regarding another issue, the FDA wrote, “… we have reviewed your March 15 and April 30 responses. We remain concerned that pouch seal visual acceptance criteria continue to include seals ranging from clear to ‘hazy whitish’ and also that seals with embedded particulate may continue to be accepted. During the inspection, an employee of your firm acknowledged that seal breaches could be missed during visual inspection of ‘hazy” seals.’”

The FDA concluded its letter by stating that “the specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

Edwards Lifesciences has 15 days to respond to the letter.

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