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It's every drug- and devicemaker’s worst nightmare — inspectors coming through your front door with the power to shut you down. They're highly trained … ruthlessly committed to spotting your tiniest flaws … and tough as nails. If only you could question investigators in detail … before an inspection. Maybe you'd learn what you need to do to pass. Would they tell you? The answer is yes.
The FDA is asking a federal judge to dismiss a lawsuit brought by six agency scientists who say they were subjected to retaliatory personnel actions as punishment for reporting device safety concerns to Congress and the U.S. Office of Special Counsel (OSC). The agency argues the staffers improperly bypassed long-standing complaint procedures for federal workers established under the Civil Service Reform Act (CSRA) and went directly to court. Drug Industry Daily