Daiichi Sankyo/Luitpold Pharmaceuticals/American Regent - Fierce's 2011 warning letters report

Like the case with Golden State Medical Supply, Luitpold Pharmaceuticals was chastised for repeat violations. Inspectors noted that the company failed to investigate instances of particle contamination and product failures during inspections in 2008, 2009 and 2010.

Glass and silicone particle contamination in injectables had driven several recalls by the drugmaker, going back to late 2010. Sister company American Regent, a Shirley, NY, distributor, conducted the recalls.

Warning Letter NYK-2011-33, to CEO Mary Jane Helenek, states that company SOPs describing when to launch an investigation into a manufacturing issue are poorly defined and not scientifically justified. The company had established a reject limit as the trigger for investigations and applied it to all products. But the SOP instructions "contradict the need for an investigation if the number of vials rejected during inspection exceeds the reject limit."

The company promised, in its response to the 483 inspection report, to review all products and apply statistical criteria to establish reject limits. But that promise stopped short of satisfying the agency: "Your response is inadequate because you do not commit to assess the different types of observed particulate matter or develop appropriate criteria for each type of particulate matter."

Daiichi Sankyo/Luitpold Pharmaceuticals/American Regent - Fierce's 2011 warning letters report
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