Menstrual Cup Maker Fails on Validations

The FDA has cited Dot International for failure to validate reprocessing instructions for its reusable menstrual cups and other quality issues observed during an inspection of its Evanston, Ill., facility.

The company’s website maintained that the menstrual cup has a 10-year use life, but the firm had not conducted use-life studies, the FDA said, noting that this was a repeat observation from a previous inspection.

The firm also implemented a design change without establishing procedures and failed to document the change.  In addition, procedures for receiving, reviewing and evaluating complaints were found to be inadequate, according to the Form 483 inspection report.