# FDA 483 - Boston Scientific Corporation - March 28, 2025

Source: https://www.keypedia.com/records/483/boston-scientific-corporation/3ff5110d-4e21-448a-971a-827202c6ccb6

> FDA 483 for Boston Scientific Corporation on March 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston Scientific Corporation
- Inspection Date: 2025-03-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: 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.

## Related Documents

- [483 - 2025-03-28](https://www.keypedia.com/records/483/boston-scientific-corporation/36294022-f2f0-4c3f-80e5-7827cad8f110)

## Related Officers

- [Satheesh K. Podaralla](https://www.keypedia.com/people/satheesh-k-podaralla/03d63e82-20fe-4d4f-b2e6-161f06840ad6)
- [Santos E. Camara](https://www.keypedia.com/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

Company: https://www.keypedia.com/companies/boston-scientific-corporation/98ea0f64-d3c5-4315-a621-cde948e3f7d7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6