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Production workers at ATS Manufacturing threw out all of the nonconforming products they found and failed to document any follow-up activities over the course of nearly four years, an FDA investigator discovered in an August 14-18 inspection. Read More
An FDA agreement to recognize good management practice reports from eight European countries, will allow the agency to reassign investigators to high-priority areas such as India and China, an official told an FDAnews inspections conference. Read More
A Chinese maker of pain-relief balms and ointments falsified results of tests on its products and deflected FDA inspectors seeking to examine its laboratory, the FDA said in a warning letter. Read More