In a September 18, 2013 press release by USFDA, federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.
A June 2012 warning letter identified repackaging technicians had changed master labels of repackaged products, which resulted in product packages labeled with incorrect strength or incorrect spelling of the drug name. An April 2010 warning letter identified a lack of validation for the practice of splitting and repackaging tablets, and a lack of cleaning validation.
To resume operations according to the consent degree – the company must first notify the FDA of their intentions. The firm will not be able to resume operations until they receive written notice from the FDA that their operations are compliant with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. Prior to resuming operations, the consent decree also requires Shamrock Medical to retain an independent expert to inspect their operations and have the expert certify to the FDA that the necessary corrections have been made. The consent decree also requires Shamrock Medical, upon resumption of its operations, to comply with CGMP regulations.