The inspection was conducted in the summer of 2012, but the federal watchdog agency said the company’s response, dated August 2012, failed to satisfy the FDA’s concerns.
"Although your firm promises to make various corrections, the response did not include supporting evidence of these corrections," according to a new warning letter, issued to the company last month and published online this week.
The FDA cited lapses in CooperSurgical’s complaint filing system, including one failure to investigate a potential patient injury, failure to follow-up on a mis-labeling issue and lack of investigation into a potential product defect that resulted in more than 220 complaints, among other issues.
"Your firm should take prompt action to correct the violations addressed in this letter," the FDA letter states. "Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties."
CooperSurgical is a wholly owned subsidiary of The Cooper Companies Inc. COO shares were up 3.1% today, trading at $114.24 as of about 3:35 p.m.
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