FDA 483 - Aunt Flow Corp - May 08, 2025

Aunt Flow Corp, a medical device specification developer in Columbus, OH, received a Form FDA 483 with seven observations, many of which are repeat issues from a previous inspection. The observations highlight significant deficiencies across multiple critical quality system areas, including supplier management, CAPA, complaint handling, design control, training, management review, and quality audits. This indicates a systemic failure to establish and implement adequate procedures for quality assurance.