FDA 483 - Horizons International Corporation - February 16, 2023

Horizons International Corporation, a medical device manufacturer in La Valencia Heredia, Costa Rica, was inspected by the FDA from February 13-16, 2023. The inspection revealed significant deficiencies in their quality system, including failures in developing MDR procedures, controlling nonconforming products, investigating complaints, and establishing adequate corrective and preventive actions. These issues indicate a lack of robust quality management practices for their Class I and Class II medical devices.