# FDA 483 - Cambrex Charles City, Inc. - May 02, 2022

Source: https://www.globalkeysolutions.net/records/483/cambrex-charles-city-inc/2fd557fc-21d0-48ec-a6ca-112f238f4867

> FDA 483 for Cambrex Charles City, Inc. on May 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambrex Charles City, Inc.
- Inspection Date: 2022-05-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Cambrex Charles City, Inc. in Charles City, IA, an API manufacturer, was cited for significant deficiencies in laboratory controls and investigation procedures. The inspection revealed issues with scientifically unsound sampling and testing for microbiological contamination and diethylene glycol, as well as untimely and incomplete investigations into manufacturing deviations. These findings indicate a lack of robust quality control and investigation practices.

## Related Documents

- [483 - 2016-12-22](https://www.globalkeysolutions.net/records/483/cambrex-charles-city-inc/afa25914-a08d-4159-8627-e6b65c1c4c54)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/cambrex-charles-city-inc/c0afd4ba-913f-4ee0-a5a0-67af6b17c8d8)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.globalkeysolutions.net/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Brent M. Dehaan](https://www.globalkeysolutions.net/people/brent-m-dehaan/7a6af4a2-2566-48af-b59d-dd59008ff997)

Company: https://www.globalkeysolutions.net/companies/cambrex-charles-city-inc/b14d342b-e5ae-4df6-ad7a-39cd62dfb9c6

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8