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

Source: https://www.keypedia.com/records/483/boston-scientific-corporation/36294022-f2f0-4c3f-80e5-7827cad8f110

> 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: San Juan District Office
- Summary: 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.

## Related Documents

- [483 - 2025-03-28](https://www.keypedia.com/records/483/boston-scientific-corporation/3ff5110d-4e21-448a-971a-827202c6ccb6)

## 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/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8