STAT May 16, 2023
On Feb. 2, the Food & Drug Administration issued an alert warning about “Made in India” artificial eye drops that were potentially contaminated with rare drug-resistant bacteria suspected to be the cause of 55 adverse events, including three deaths and several other cases of vision loss from eye infections.
These unfortunate events should not come as a surprise. The FDA frequently announces import alerts for Indian drug manufacturing facilities because of their failure to comply with good manufacturing practices spelled out under U.S. law. As Katherine Eban documents in “Bottle of Lies,” American drug inspectors conducting their annual visits to Indian plants often find violations that range from unhygienic conditions at the manufacturing facilities to brazen data fraud in which...
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