Group wants FDA to include Indian regulators on plant visits – FiercePharma Manufacturing
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Last year, as tensions grew between the U.S. and India over plants the FDA had banned, the head of the FDA’s operation in India said that the agency would start inviting Indian drug inspectors along on plant inspections. The idea was to allow them to learn what the U.S. expected from manufacturers. Now the Indian government is insisting on it.
Read more – FiercePharma Manufacturing
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I can understand why they would like to be invited along on inspections, however, this makes the chance that there is ever truly a “surprise” inspection quite remote…