On March 3, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Tentamus India Private Limited. The inspection it describes started the way most do, with one difference. At the initiation of the inspection, the agency’s investigator observed the firm attempting to remove two large garbage bags from the site. The bags were later determined to contain analytical documents, torn up. Among them were impurity method validation spreadsheets, on paper. The firm’s own procedure called for those originals to be retained.

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