FDA’s Dallas District Office warns Electromedical Products International about Quality System Regulation and other violations in its manufacturing of a microcurrent and cranial stimulator.
In it latest batch of Warning Letters, FDA cites Desert Rose Manufacturing, Electromedical Products, Entrenet Nutritionals, Interlab, Juve International, Rubimed, Shippert Medical Technologies, SmartPractice Denmark, and Weber Medical.
FDA human factors specialist QuynhNhu Nguyen describes as “extraordinary” the number of comments the agency has received on its 2011 draft guidance, and gives other insights on the issue.
The House Committee on Energy and Commerce votes to advance legislation to the House floor on securing the U.S. prescription drug supply chain and reauthorize two important drug user fee programs for new and generic animal drugs.