The Food and Drug Administration’s 2022 inspection of the Sun Pharma factory in India warned of contaminations and deficiencies. But the plant received permission from the FDA to continue shipping more than a dozen generic medications to Americans.
We are still reporting. If you are a current or former FDA employee or someone in the industry with information about the agency, the safety of generic drugs, or the manufacturers that make them, our team wants to hear from you. Megan Rose can be reached on Signal or WhatsApp at 202-805-4865. Debbie Cenziper can be reached on Signal or WhatsApp at 301-222-3133. You can also email us at [email protected].
Reporting Highlights Risky Medications: The FDA has given more than 20 foreign factories a special pass to continue sending drugs to the U.S. even though they were made at plants that the agency had banned.
The FDA has given more than 20 foreign factories a special pass to continue sending drugs to the U.S. even though they were made at plants that the agency had banned. Troubled Factories: The medications came mostly from plants in India where inspectors found contaminated drugs, filthy labs and falsified records.
The medications came mostly from plants in India where inspectors found contaminated drugs, filthy labs and falsified records. FDA Secrecy: The agency did not proactively inform the public when drugs were exempted from import bans, and it did not routinely test the medications to ensure they were safe. These highlights were written by the reporters and editors who worked on this story.
On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside.
For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans.
Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were “blackish” from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown “extraneous matter” were used anyway, mixed into batches of drugs.
Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.
But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America’s drug supply.
... continue reading