483
Fenwal International, Inc.FDA 483 - Fenwal International, Inc. - April 25, 2023
Record Details
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.
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ID · 5f4657e4-6ed1-4f69-9447-bd7e983c624a