FDA 483 - Fenwal International, Inc. - April 25, 2023

Fenwal International, Inc., a medical device manufacturer in Bajos De Haina, Dominican Republic, was cited with seven observations during an FDA inspection from April 17-25, 2023. The inspection revealed significant deficiencies in quality system procedures, including inadequate control of non-conforming products, insufficient corrective and preventive actions, unsuitable building design for cleanroom operations, and poor equipment maintenance and process control. These issues indicate a systemic lack of adherence to quality system regulations for medical device manufacturing.