FDAnews Device Daily Bulletin

QUALITY SYSTEM DEFICIENCIES WILL TAKE YEARS TO FIX, AJP SAYS

May 19, 2006
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Correcting quality system (QS) deficiencies will be costly for one New Jersey firm that recently received an FDA warning letter.

According to the March 2 warning letter, company executives failed to establish QS procedures for the production of their fetal hemoglobin differential staining kit and their semen analysis kit.

Henry Eng, president of AJP Scientific, said it would cost two to three years of product sales to address FDA concerns. "I've had to hire a consultant just to handle this," he said. "I don't understand what [the FDA is] looking for."

Specifically, the FDA found that AJP Scientific (also known as Eng Scientific) did not establish procedures for implementing corrective and preventive actions. According to the letter, methods were not established for analyzing and documenting potential causes of, or corrective actions to, nonconforming kits. The company also did not have procedures for handling and disposing nonconforming kits, the letter stated. ()a href="http://www.fdanews.com/ddl/33_20/" target=_blank>