# FDA 483 - Boehringer Ingelheim Pharmaceuticals, Inc. - December 12, 2019

Source: https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-pharmaceuticals-inc/da8d3965-3386-4e4e-9c75-c73516a4a7a1

> FDA 483 for Boehringer Ingelheim Pharmaceuticals, Inc. on December 12, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Pharmaceuticals, Inc.
- Inspection Date: 2019-12-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT, identified significant deficiencies in their role as a sponsor of clinical investigations. The firm failed to notify the FDA of clinical investigators terminated for cause and did not ensure investigations adhered to the general investigational plan and protocols. Additionally, the company failed to retain required Data Monitoring Committee meeting minutes for the specified period.

## Related Documents

- [EIR - 2010-09-01](https://www.globalkeysolutions.net/records/eir/boehringer-ingelheim-pharmaceuticals-inc/c2f00c08-0e01-4f3f-bbfa-5466b71914d6)
- [483 - 2025-09-11](https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-pharmaceuticals-inc/bc781480-aeee-407e-a25b-cb006433ea7d)
- [483 - 2025-09-11](https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-pharmaceuticals-inc/6394b726-4080-4f87-8203-78db8a187c7a)

## Related Officers

- [Miah Jung](https://www.globalkeysolutions.net/people/miah-jung/8d4c33e9-7fd9-4a9d-856b-05a24e1566d4)
- [Cynthia Kleppinger](https://www.globalkeysolutions.net/people/cynthia-kleppinger/8badb3bc-141f-4094-a02b-b572fdb68fbf)
- [Regulatory Officer](https://www.globalkeysolutions.net/people/peter-r-lenahan/c695dac2-5447-434b-801e-f95e6acf05f1)

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

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248