FDA 483 - Hygeia II Medical Group, Inc. - August 02, 2023

An FDA inspection of Hygeia II Medical Group, Inc. in Carlsbad, CA, a specification developer of Class II powered breast pump devices, revealed significant deficiencies in their quality system. Observations included a failure to initiate CAPAs for numerous complaints, inadequate procedures for incoming product acceptance, and incomplete complaint investigation records. The firm also lacked adequate procedures for product identification and traceability for currently marketed devices, while continuing to ship affected products.