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Intuitive Surgical reveals details of FDA warning letter, follow-up visit

Tue, 07/23/2013 - 3:27pm
Mass Device

The FDA cites 4 "objectionable observations" following an inspection of Intuitive Surgical's facilities, and the agency plans to make a follow-up visit to take a closer look at recall procedures.

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Robot surgical devices maker Intuitive Surgical (NSDQ:ISRG) has had a rough few months, and the tension wasn't much eased by news that the company had been the subject of an FDA warning letter following a facilities inspection.

In its most recent financial report, Intuitive said that the FDA had issued a Form FDA 483 warning citing 4 "objectionable observations" from the inspection.

"These 4 observations relate to the reporting of field actions, information which is to be included on reports of field actions, lack of a written procedure for changes to certain product claims, and design input documentation," according to a company financial report. "In addition, the FDA collected in electronic form, samples of all advertising and promotional material for review."

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