FDA 483 - Fenwal International, Inc. - February 05, 2026

An FDA inspection of Fenwal International, Inc. in Maricao, PR, revealed significant deficiencies in their manufacturing operations, particularly concerning production and process controls, quality unit oversight, and facility maintenance. The firm released products with out-of-specification bioburden and failed to adequately investigate contamination issues, indicating a systemic lack of adherence to established quality standards. Many of these issues were repeat observations from previous inspections, highlighting persistent problems.