The FDA handed a warning letter to Anigan for numerous GMP violations it uncovered during an April 2018 inspection of the firm’s San Ramon, California facility.

The agency issued the devicemaker a Form 483 on April 19 at the close of the inspection for failure to establish design control procedures, validation procedures, risk analysis, or complaint handling procedures for its Class II Super Jennie and EvaCup reusable menstrual cups.

The company provided a design control procedure during the inspection, but it didn’t have an implementation date or evidence that it had been reviewed or approved.