Warning Letter: Cody Laboratories

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:

• qualification and acceptance records for the plant's reverse-osmosis water system (21 CFR211.68a);

• adherence standard operating procedures for maintaining thewater system and its components (21 CFR 211.100b);

• written programs for maintaining equipment (21 CFR 211.68);

• a lack of studies to assure that the air filtration systemperformed properly (21 CFR211.46);

• inadequate written procedures for equipment cleaning andmaintenance (21 CFR 211.67b);

• failure to investigate an out-of-specification batch (21 CFR 211.192);

• unsigned master production and control records (21 CFR 211.186a);

• omission from the master production and control records ofsigned theoretical yields, specimen labels (21 CFR 211.186b);

• inadequate washing facilities easily accessible to all workers(21 CFR 211.52);

• lack of written procedures for reviewing complaints and adverse drug reactions (21 CFR211.198a).