# FDA 483 - Boehringer Ingelheim Animal Health Puerto Rico LLC - March 29, 2019

Source: https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-animal-health-puerto-rico-llc/e7c75bb9-7697-4b58-98bd-2383b57280ca

> FDA 483 for Boehringer Ingelheim Animal Health Puerto Rico LLC on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Animal Health Puerto Rico LLC
- Inspection Date: 2019-03-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Boehringer Ingelheim Animal Health Puerto Rico LLC in Barceloneta, PR, revealed a significant failure to thoroughly review unexplained discrepancies. The firm did not adequately investigate out-of-specification environmental monitoring events or take sufficient action to mitigate recurring issues in a high-risk manufacturing area. This indicates deficiencies in their quality operations and investigation processes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.globalkeysolutions.net/companies/boehringer-ingelheim-animal-health-puerto-rico-llc/71ca6660-e983-45d5-95f0-27dae38a9226

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