# FDA 483 - Corden Pharma Colorado, Inc. - June 28, 2013

Source: https://www.keypedia.com/records/483/corden-pharma-colorado-inc/f4c04a32-b1f1-46fe-9b43-fe35ef8901ac

> FDA 483 for Corden Pharma Colorado, Inc. on June 28, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Corden Pharma Colorado, Inc.
- Inspection Date: 2013-06-28
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Cordon Pharma Colorado, Inc. in Boulder, CO, an API manufacturer, revealed significant deficiencies in quality control, facility maintenance, and adherence to internal procedures. Observations included a lack of thorough investigation into out-of-specification incidents, unsanitary conditions in the raw material sampling room, and failures to follow incident reporting and investigation protocols.

## Related Documents

- [483 - 2019-02-06](https://www.keypedia.com/records/483/corden-pharma-colorado-inc/1ecff09c-58d5-46d5-b79c-fb60a9edb3ff)

## Related Officers

- [Elisa Reed](https://www.keypedia.com/people/elisa-reed/6b2c814c-1093-4042-890c-036f14838759)
- [Consumer Safety Officer  ](https://www.keypedia.com/people/kimberley-a-hoefen/eb3bc154-a71e-4cc7-af25-9a6f0810d239)
- [Consumer Safety Officer](https://www.keypedia.com/people/jamie-dion/f6ae304e-f074-408c-935f-f1aac91cdb55)

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

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face