AccuMed Inspections Lead to Leadership Changes

AccuMed has changed the leadership of its quality control unit (QCU) after two FDA inspections found the QCU did not follow the company’s standard operating procedures, according to a recent warning letter.

The agency requests full details about the organizational changes. The drugmaker also must explain how the new leadership will ensure the QCU identifies and corrects the deficiencies and prevents recurrences, according to the June 24 letter posted recently on the FDA’s website.

The FDA cited the Lawrenceville, N.J.-based company for several GMP violations, including a packaging error involving one of its medications and failure to notify the FDA in a timely manner about the subsequent recall of the medicine. AccuMed is working to address and correct the issues as soon as possible, a company spokesperson said.
Drug GMP Report