FDA 483 - Boston Scientific Corporation - March 28, 2025

Boston Scientific Corporation in Dorado, PR, a combination drug manufacturer, was cited for seven significant deficiencies during an FDA inspection. Observations included an inadequate stability testing program, failure to determine theoretical yields, and deficient batch production and control records. Additionally, the firm failed to properly store and examine reserve and active pharmaceutical ingredient samples, maintain manufacturing facilities in good repair, and follow up on drug complaint investigations.