# FDA 483 - Corden Pharma Colorado, Inc. - February 06, 2019

Source: https://www.keypedia.com/records/483/corden-pharma-colorado-inc/1ecff09c-58d5-46d5-b79c-fb60a9edb3ff

> FDA 483 for Corden Pharma Colorado, Inc. on February 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corden Pharma Colorado, Inc.
- Inspection Date: 2019-02-06
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Corden Pharma Colorado, Inc. in Boulder, CO, an Active Pharmaceutical Ingredient Manufacturer, was inspected by the FDA from January 30 to February 6, 2019. The inspection revealed a significant issue regarding the firm's quality control procedures, specifically the failure to justify deviations from written test procedures for microbiological media and to properly qualify media suppliers. This indicates a lack of adequate controls over critical laboratory processes and materials.

## Related Documents

- [483 - 2013-06-28](https://www.keypedia.com/records/483/corden-pharma-colorado-inc/f4c04a32-b1f1-46fe-9b43-fe35ef8901ac)

## Related Officers

- [Senior Lead Reviewer and Intercenter Consult Team Leader](https://www.keypedia.com/people/nayan-j-patel/0436f014-4b1b-4e54-8df0-576d51a354b2)

Company: https://www.keypedia.com/companies/corden-pharma-colorado-inc/d47254de-6718-4960-b0eb-0768d896cdc0

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6