# FDA 483 - Boehringer Ingelheim Fremont, Inc. - August 24, 2018

Source: https://www.keypedia.com/records/483/boehringer-ingelheim-fremont-inc/eaf43242-79af-4cd0-b066-41ff35c67a2d

> FDA 483 for Boehringer Ingelheim Fremont, Inc. on August 24, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Fremont, Inc.
- Inspection Date: 2018-08-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Boehringer Ingelheim Fremont, Inc., a combination sterile drug/device manufacturer in Fremont, CA, was cited for five observations during an FDA inspection. The observations primarily concern inadequate validation of packaging and equipment, insufficient control over equipment used for quality checks and training, failure to follow stability testing procedures, and inadequate investigations into deviations. Additionally, critical raw material specifications were found to be incomplete, indicating several significant quality system deficiencies.

## Related Documents

- [483 - 2017-04-04](https://www.keypedia.com/records/483/boehringer-ingelheim-fremont-inc/22dda148-a183-4658-941d-070cff867701)
- [483 - 2022-11-04](https://www.keypedia.com/records/483/boehringer-ingelheim-fremont-inc/9e6e4169-d682-4b30-8ddd-4857a586bbf4)

## Related Officers

- [Senior Consumer Safety Officer ](https://www.keypedia.com/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)
- [Compliance Officer - CDER/OC/OMQ](https://www.keypedia.com/people/anita-narula/fbebf5a2-e25c-4e98-9c22-433d9102380c)

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

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