Ningbo Smart Pharmaceutical has felt the sting of an FDA warning letter over quality control problems and the company's failure to register and list APIs it distributes in the U.S. CDER director Richard Friedman writes to company chairman Grant Wu about three violations concerning raw material and finished product testing.
There's no doubt that the FDA is increasing foreign inspections. It conducted about 2,000 in 2010 and "evidence suggests this number will grow dramatically in FY11," writes Tony Chen of FDAzilla in the report, "Top Seven Strategies for Avoiding 483s."
The first two of the three concern raw materials released by the QC unit. Inspectors found that no testing was done for certain impurities and for material identity, yet documentation indicates the tests were done, and the materials met spec.
"This serious deviation raises concerns regarding the reliability and integrity of other data," writes Friedman. He dismisses the company's commitment to improve its quality control unit--stated in response to the Form 483 inspection report that followed the FDA visit--as inadequate to determine "the extent and impact of the problem."
The remaining deviation cites a lack of testing in finished API lots that were released.