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5.1 Somerset Therapeutics (India): Ignoring Visible Evidence Somerset Therapeutics Private Limited (Warning Letter 320-25-XX, September 4, 2025) failed to investigate visible contamination.(3) The Violation: The firm experienced a media fill failure involving extensive contamination that was "visible to the human eye coming off the line." The Investigation Failure: Despite this gross failure, the investigation lacked data supporting the assigned root cause and failed to expand the scope to all potentially affected drug products
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