Judge Approves Consent Decree Against Shamrock Medical Solutions Group
A federal judge has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, 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, the FDA reported in a press statement on Sept. 18.
Shamrock Medical repackaged and distributed solid and liquid oral non-sterile drug products for human use to hospitals throughout the United States. FDA reported that inspections found several violations at the facility, including failure by the quality control unit to fully follow its own quality control procedures and to examine packaged and labeled products to ensure correct labeling. The FDA previously had sent warning letters to Shamrock Medical for violating cGMPs and distributing incorrectly labeled drugs.
This announcement follows an FDA alert issued in April 2013 advising health care providers to remove drugs distributed by Shamrock Medical from supply stock due to the possibility that they were mislabeled. The warning covered many non-sterile medications and dosage forms, including tablets, vials, ophthalmic and otic solutions, and patches. Shamrock Medical’s representatives informed the court that they are no longer repackaging or distributing any drugs.
According to the consent decree approved by Judge Algenon L. Marbley of the Southern District of Ohio, if Shamrock Medical decides to resume operations, the company must first notify the FDA of their intention and 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.
In addition, the company is required to retain an independent expert to inspect their operations and have the expert certify to the FDA that the necessary corrections have been made, prior to resuming operations. FDA reports it has not received reports of harm to patients from use of these drug products; the agency does not anticipate a drug shortage as a result of today’s consent decree.