Warning Letter: Cody Laboratories

April 20, 0006

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:

  • 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).