Corden Pharma Colorado, Inc.June 28, 2013

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

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Record Details

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.

Company: Corden Pharma Colorado, Inc.
Inspection Date: June 28, 2013
Product Type: Drugs
Office: Denver District Office
People: Elisa Reed
Kimberley A. Hoefen (Consumer Safety Officer )
Jamie Dion (Consumer Safety Officer)

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ID · f4c04a32-b1f1-46fe-9b43-fe35ef8901ac