Cosmetic Devicemaker Fails to Submit MDRs on Time

The FDA cited Carol Cole Company 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 that was 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, and it failed to follow up with end users or to report the adverse events, the 483 says.

The investigators noted that 10 of 11 complaint records were not closed within the required timeframe, and all 11 of the complaint investigations lacked a review of quality records. The 483 notes that the firm lacked procedures for receiving, reviewing and evaluating complaints by a formally designated unit.

Read the Carol Cole Company Form 483 here: www.fdanews.com/06-20-19-carolcoleco483.pdf.