# FDA 483 - Boehringer Ingelheim Pharmaceuticals, Inc. - September 11, 2025

Source: https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-pharmaceuticals-inc/6394b726-4080-4f87-8203-78db8a187c7a

> FDA 483 for Boehringer Ingelheim Pharmaceuticals, Inc. on September 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Pharmaceuticals, Inc.
- Inspection Date: 2025-09-11
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT, identified a significant issue regarding their clinical trial sponsor responsibilities. The firm failed to adhere to its Trial Statistical Analysis Plan by not excluding data associated with important protocol deviations from supplementary analyses. This oversight may compromise the integrity and reliability of the clinical trial data and results.

## Related Documents

- [EIR - 2010-09-01](https://www.globalkeysolutions.net/records/eir/boehringer-ingelheim-pharmaceuticals-inc/c2f00c08-0e01-4f3f-bbfa-5466b71914d6)
- [483 - 2019-12-12](https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-pharmaceuticals-inc/da8d3965-3386-4e4e-9c75-c73516a4a7a1)
- [483 - 2025-09-11](https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-pharmaceuticals-inc/bc781480-aeee-407e-a25b-cb006433ea7d)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/boehringer-ingelheim-pharmaceuticals-inc/437c28a1-054f-4c22-9dba-fd40af58a7be

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144