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."
The agency is planning a come-back visit to take a closer look at the company’s recall procedures, senior finance director Calvin Darling said in a recent earnings call.
Intuitive responded to each of the observations both during the inspection and afterwards, according to the company. The FDA nonetheless issued a warning letter dated July 16 and informed the company that inspectors will come back for a follow-up tour of the facilities.
"We believe that the FDA’s observations are addressable and we are in the process of correcting them," Intuitive Surgical reported.
The inspection and news of the warning letter dragged ISRG shares down when they were 1st reported in June. The plunge was the latest in a slew of Wall Street slides that have cut 31%, amounting to more than $177 per share, from ISRG prices the start of February.
In recent months the company, once a Wall Street darling, has faced an FDA probe into surgical complication rates, an American Congress of Obstetricians & Gynecologists statement questioning the benefits of da Vinci surgery, a high-profile patient injury lawsuit painting the company as an aggressor, a surgical instrument crack warning and a shareholder class action lawsuit against the company and its leadership.