ePT--the Electronic Newsletter of Pharmaceutical Technology
On April 7, the US Food and Drug Administration's Denver District Office (Denver, CO), issued a Warning Letter to Cody Laboratories (Cody, WY), citing the results of a ten-day March 2005 inspection of the company's production of hydromorphone hydrochloride active pharmaceutical ingredient and morphine sulfate concentrate oral solution drug product?and Cody Labs' four written responses.
On April 7, the US Food and Drug Administration's Denver DistrictOffice (Denver, CO) issued a Warning Letter (http://www.fda.gov/foi/warning_letters/g5798d.htm)to Cody Laboratories (Cody, WY, www.codylabs.com) citing the results of a ten-dayMarch 2005 inspection of the company's production of hydromorphonehydrochloride active pharmaceutical ingredient and morphine sulfateconcentrate oral solution drug product---and Cody Labs' four writtenresponses.
The Warning found fault with: