Document Shredding at Night Raises FDA Eyebrows During India Visit
- FDA quizzes three companies about potential quality breaches
- December reports may portend additional regulatory setbacks
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One Indian pharmaceutical firm’s nighttime document-shredding and potential manufacturing lapses at two others since December are reigniting concerns that, despite recent efforts, the country’s generic-drug industry still has a way to go to gain the trust of U.S. regulators.
U.S. Food and Drug Administration inspectors observed paperwork being shredded at 1 a.m. in the document storage area of a factory owned by Hetero Labs Ltd., according to a report on the regulator’s website. Separately, two other drugmakers, including India’s largest, were informed of potential factory violations last month.