FDA 483 - Boston Scientific Corporation - March 28, 2025

Boston Scientific Corporation, a combination drug manufacturer in Dorado, PR, received a Form 483 with seven observations. The inspection revealed significant deficiencies in the firm's quality systems, including inadequate stability testing, lack of yield calculations, incomplete batch records, and improper storage of active pharmaceutical ingredients. Additionally, issues were noted with reserve sample examination, facility maintenance, and follow-up on drug complaint investigations.