Consent decree halts operations of Ohio drug manufacturer
Lewis Center, Ohio-based Shamrock, which repackages and distributes solid and liquid oral non-sterile drugs to hospitals nationwide, can effectively no longer operate its business.
Recent FDA inspections found several cGMP violations at the facility, including the quality control unit’s failure to fully follow its quality control procedures and to examine packaged and labeled products to ensure correct labeling.
The FDA previously sent warning letters to Shamrock for violating cGMP practices and distributing incorrectly labeled drugs. The agency also alerted health providers last April that Shamrock was mislabelling drugs and that all products from the company should be discarded and removed. That warning included non-sterile tablets, vials, ophthalmic and optic solutions, and patches.
For example, Shamrock distributed drug labels that described a different drug than what was included in the container; a drug with the wrong dosage strength; and a drug not identified as extended release.
Shamrock Medical’s representatives told the court that they are no longer repackaging or distributing any drugs, though the company did not respond to a request for comment.
“This company continued to distribute mislabeled drugs despite previous warnings by the FDA,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs.
According to the consent decree, if Shamrock Medical decides to resume operations, 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 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 FDA said it has not received any reports of harm to patients from use of these drugs and no drug shortages are expected as a result of the consent decree.
