cGMPs / QRM Process

Could the FDA Have Prevented Recent Bacterial Infections?

Source: PharmaManufacturing.com

Aug 15, 2013

pharmalive.com

 
The U.S. Food and Drug Administration announced on Sunday that Specialty Compounding LLC will voluntary recall its full line of sterile products used to inject drugs, citing concerns about bacterial bloodstream infections.

However, the contention was made by consumer watchdog Public Citizen that the FDA issued an inspection report last March showing that Specialty Compounding, which is based in Dallas, failed to take steps to prevent microbiological contamination, among other problems. But the agency did not issue a safety notice or pressure the company to conduct a voluntary recall.

The recent recall was issued after the FDA received reports of 15 bacterial infections at two Texas hospitals that were “potentially related” to the company's calcium gluconate infusions. 

In a letter to the Kathleen Sebelius, the secretary of the US Department of Health & Human Services, Public Citizen writes that the FDA could and should have taken action to prevent the infections after its March inspection. And the advocacy group wants Sebelius to order the HHS Office of Inspector General to investigate why the FDA did not press the compounder to conduct a recall sooner. Read more