# FDA 483 - Boehringer Ingelheim Pharma GmbH & Co. KG - May 01, 2026

Source: https://www.keypedia.com/records/483/boehringer-ingelheim-pharma-gmbh-co-kg/bd8df4e5-26ea-4b1c-b318-17015aa2448a

> FDA 483 for Boehringer Ingelheim Pharma GmbH & Co. KG on May 01, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Pharma GmbH & Co. KG
- Inspection Date: 2026-05-01
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Boehringer Ingelheim Pharma GmbH & Co. KG, a finished drug and API manufacturer, revealed significant deficiencies in record-keeping, process validation, and quality control. Observations included incomplete inventory reconciliation, lack of process validation for solvent recovery, inadequate deviation investigations, and insufficient documentation of critical manufacturing steps and line clearances. These issues indicate a need for improved adherence to good manufacturing practices.

## Related Officers

- [Christopher S. Keating](https://www.keypedia.com/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)

Company: https://www.keypedia.com/companies/boehringer-ingelheim-pharma-gmbh-co-kg/bcb705bf-98ed-451f-a79d-b6223d2ed263

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4