Company: Shamrock Medical Solutions Group
Plant: Lewis Center, OH
Warning letter: June 15, 2012
Along with our ninth featured citation to Gulf Pharmaceutical Industries, this letter demonstrates that manufacturers will probably need to give more consideration to IT security and adequacy issues.
For Shamrock Medical Solutions Group, its problems were a little more obvious because it released drugs that were mislabeled by technicians who had access to the master label file. Making that one particularly bad was the fact that the agency had earlier warned against unauthorized users having access to label files and the company said it would change its IT authorization procedures.