Menstrual Cup Maker Anigan Warned for Serious GMP Violations
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.
“You told our investigator it became effective on April 6, 2018, and that prior to that date your firm had not established design controls for your menstrual cups since 2014,” the agency said.
In its response to the 483, Anigan said it hired a consultant and would have a plan in place by June 30 for retroactively completing the design controls. However, the FDA said the devicemaker hadn’t provided any objective evidence of corrections and it hadn’t addressed how it would ensure products distributed would conform to user needs.
At the time of the inspection, the firm had no evidence that it had validated designs for either the EvaCup or the Super Jennie cup. The firm provided instructions for use that recommended cleaning the cups in boiling water to initially sterilize them, but it had not conducted validation studies or risk analyses for either of the devices.
The FDA also took issue with Anigan for its inability to determine if the devices meet specifications, noting it did not establish specifications for all of its packaging and labeling, and it had no device acceptance records.