# FDA 483 - Cambrex Charles City, Inc. - December 22, 2016

Source: https://www.globalkeysolutions.net/records/483/cambrex-charles-city-inc/afa25914-a08d-4159-8627-e6b65c1c4c54

> FDA 483 for Cambrex Charles City, Inc. on December 22, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambrex Charles City, Inc.
- Inspection Date: 2016-12-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Cambrex Charles City, Inc. in Charles City, Iowa, was inspected, revealing two significant issues. The firm failed to properly execute its product recall procedures, including classifying a recall and notifying the FDA. Additionally, the inspection found inadequate written procedures for equipment cleaning, leading to observed residue on manufacturing equipment.

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## Related Officers

- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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