FDA 483 - Anigan, Inc. - April 19, 2018

Anigan, Inc., a manufacturer of Class II menstrual cups (EvaCup and Super Jennie) in San Ramon, CA, was inspected and found to have significant deficiencies across its quality system. The firm failed to establish and implement basic procedures for design control, design validation, risk analysis, complaint handling, quality audits, management review, purchasing controls, finished device acceptance, and document control. These issues indicate a fundamental lack of a compliant quality system for medical device manufacturing and distribution.