Lax Water Testing Lands Generic Drugmaker 483
High Chemical Company’s stalled investigation into color changes of its generic products and use of dirty water resulted in a Form 483.
The company’s Levittown, Pa., facility was inspected by the FDA in September 2014. The agency found that High Chemical, a division of National Generic Distributors, didn’t properly test its distilled water.
Investigators found that three out of eight receipts of distilled water in the past two years failed total organic carbon testing but were released and used in production anyway.
The agency also found that an investigation into a color change and appearance failure for a finished product lot wasn’t completed. The lack of investigation was first cited during a 2012 inspection, however, samples of the drugs weren’t provided to a laboratory for analysis until June 2014.
“The investigation remains in progress so no preventive action has been taken,” said the form with eight observations.
The agency also found High Chemical didn’t check the reliability of a supplier’s certificate of analysis for raw materials at appropriate intervals.
High Chemical did not return a request for comment as of press time.
The Form 483 can be accessed at www.fdanews.com/12-30-14-HighChemical483.pdf.