FDA 483 - Aunt Flow Corp - October 07, 2021

Aunt Flow Corp, a medical device importer and distributor in Columbus, OH, was inspected by the FDA and received eight observations. The inspection revealed significant deficiencies across its quality system, citing a complete lack of established procedures for critical areas such as complaint handling, training, quality audits, design control, purchasing controls, quality policy, management review, and document control. These findings indicate a fundamental absence of a compliant quality management system.