Cosmetic Devicemaker Fails to Submit Timely Reports

June 20, 2019

Carol Cole Company was cited for failure to submit timely medical device reports of its devices that use microcurrents to tone, firm and reduce wrinkles, according to a Form 483 issued following a March 20-22 inspection of the firm’s Vista, Calif. facility.

The firm received at least five complaints that involved reported burns to the face, but failed to follow up with end users or to report the adverse events to the FDA, the 483 says.

The investigators noted that 10 of 11 complaint records were not closed within the required timeframe, and the documented complaint investigations did not include reviews of quality records.

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