# FDA 483 - Cambrex Charles City, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/cambrex-charles-city-inc/c0afd4ba-913f-4ee0-a5a0-67af6b17c8d8

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

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## Details

- Record Type: 483
- Company Name: Cambrex Charles City, Inc.
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Cambrex Charles City, Inc, an Active Pharmaceutical Ingredient Manufacturer, was cited for two observations during an FDA inspection. The firm failed to adequately investigate unexplained discrepancies, specifically an interfering chromatographic peak, and did not consistently follow written procedures for retain sample collection. These issues indicate deficiencies in quality control and adherence to established manufacturing practices.

## Related Documents

- [483 - 2016-12-22](https://www.globalkeysolutions.net/records/483/cambrex-charles-city-inc/afa25914-a08d-4159-8627-e6b65c1c4c54)
- [483 - 2022-05-02](https://www.globalkeysolutions.net/records/483/cambrex-charles-city-inc/2fd557fc-21d0-48ec-a6ca-112f238f4867)

## Related Officers

- [Supreet K. Sran](https://www.globalkeysolutions.net/people/supreet-k-sran/1dab51f8-b483-4ccb-8b44-89fdc3b8100b)
- [Michele L. Olsen](https://www.globalkeysolutions.net/people/michele-l-olsen/b48a87a0-4e04-4609-ae93-6c13f607de04)
- [Jamilia Rizzolo](https://www.globalkeysolutions.net/people/jamilia-rizzolo/cef16775-8fcb-45d2-ad49-e2741ea5635d)

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