Pherdal Fertility Science, Inc. – FDA 483, Jul 9, 2026

An FDA inspection of Pherdal Fertility Science, Inc. in Dixon, IL, revealed significant deficiencies in their quality management system. The firm failed to effectively implement and maintain its quality system prior to the inspection, including a lack of established written procedures and inadequate supplier evaluation practices. These issues indicate a fundamental breakdown in regulatory compliance for their Class II medical devices.