483
Corden Pharma Colorado, Inc.Corden Pharma Colorado, Inc. – FDA 483, Jun 28, 2013
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.
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ID · f4c04a32-b1f1-46fe-9b43-fe35ef8901ac
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