# FDA 483 - Boehringer Ingelheim Fremont, Inc. - November 04, 2022

Source: https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-fremont-inc/9e6e4169-d682-4b30-8ddd-4857a586bbf4

> FDA 483 for Boehringer Ingelheim Fremont, Inc. on November 04, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Fremont, Inc.
- Inspection Date: 2022-11-04
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Boehringer Ingelheim Fremont, Inc. from October 25 to November 4, 2022, revealed significant deficiencies in the firm's quality control unit. The inspection found that procedures for logbook review and deviation documentation were not adequately written or followed. Additionally, process description documents contained non-quantitative statements allowing for undocumented transient excursions from operating parameters.

## Related Documents

- [483 - 2017-04-04](https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-fremont-inc/22dda148-a183-4658-941d-070cff867701)
- [483 - 2018-08-24](https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-fremont-inc/eaf43242-79af-4cd0-b066-41ff35c67a2d)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.globalkeysolutions.net/companies/boehringer-ingelheim-fremont-inc/3d7d0ca7-27cd-4223-8ade-7193417c9861

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b