FDA flags breakdowns at Indian pharma factory exporting to the US
US inspectors have uncovered new and dangerous breakdowns in drugmaking at an Indian factory owned by Sun Pharma that produces generic medications for American consumers.
The latest problems come 2 1/2 years after the Food and Drug Administration gave the facility a special pass to continue sending certain drugs made there to the United States, even after the factory was officially banned from the US market.
The factory failed to investigate the source of bacteria found in test vials or deal with damaged equipment that had caused drugs to be contaminated with metal particles, according to the June inspection report, which ProPublica obtained through a Freedom of Information Act request.
Workers improperly handled vials and stoppers meant for sterile medications and, in some cases, failed to disinfect manufacturing areas and equipment, according to the report. One FDA inspector saw a worker put on a sterile gown and then brush up against a waste bin and use their hands to push down the overflowing trash. Investigators also saw liquid dripping through ceiling cracks and the growth of what appeared to be fungus and mold in a storage area for samples used for testing.
The FDA in late 2022 had banned the factory in the city of Halol from shipping drugs to the United States because of similar manufacturing failures.
ProPublica reported last month that a low-profile group inside the agency at the same time exempted some medications from that ban, ostensibly to prevent drug shortages. The FDA has granted similar exemptions for drugs made at more than 20 other foreign factories that violated critical standards in drugmaking and were barred from the US market.
The FDA kept the practice largely hidden from the public. The agency did not regularly test drugs coming from the banned factories or proactively monitor reports about potential harm among consumers, ProPublica found.
In Sun's case, more than a dozen drugs were initially excluded from the Halol import ban. The company is still allowed to send five to the United States, government records show, including vecuronium bromide, a muscle relaxer used during surgery, and the cancer drug doxorubicin. Also excluded are divalproex delayed release tablets, which treat seizures and other conditions; leuprolide injection, used by people with prostate cancer, endometriosis and other conditions; and temozolomide capsules, for brain cancer.
The inspection last month marked the first time the FDA had been back to the factory in the 2.5 years since it imposed the import ban and Sun started sending exempted drugs to the United States. Inspectors found that procedures designed to prevent microbiological contamination of sterile drugs were not established or followed and that equipment wasn't maintained to prevent malfunctions that would 'alter the safety, identity, strength, quality or purity of the drug product,' according to the report.
Some of the concerns focused on the exempted drugs still being sent to the United States, according to a person familiar with the situation who did not want to be named because they were not authorized to speak publicly. The FDA blacked out the names of the drugs that were potentially compromised on its publicly released inspection report, including a medication made on a manufacturing line in which several batches had to be rejected because they were filled with black particles.
'It's disappointing to see issues continue to come up at this site given the site's role in potentially manufacturing critical drugs for US consumers,' said the person familiar with the inspection findings.
Sun did not respond to questions about the latest inspection or its regulatory history with the FDA. In an email, the company said that adherence to quality standards 'is a top priority for Sun, and we maintain a relentless focus on quality and compliance to ensure the uninterrupted supply of medicines to our customers and patients worldwide. We continue to work proactively with the US FDA and remain committed to achieve full resolution of any FDA regulatory issues at our facilities.'
The FDA said factories that receive exemptions from import bans are required to conduct extra testing on drugs with third-party oversight before they are sent to the United States, helping to ensure patient safety. Sun's Halol plant, however, was cited in 2022 and again last month for failing to thoroughly investigate unexplained quality problems, including impurities, found during drug testing. The FDA did not respond to a request for comment about the latest Sun inspection.
US Rep. Debbie Dingell, D-Michigan, who recently co-sponsored a bill to lower prescription drug costs, said in a statement to ProPublica that the FDA has a responsibility to ensure that drugs coming into the country are safe.
'We need full transparency about the extent to which exemptions enabled sub-par, unsafe, or ineffective drugs to be distributed to American patients,' she said.
Medill Investigative Lab student Katherine Dailey contributed reporting . Sign up to receive ProPublica's biggest stories as soon as they're published.
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This article was originally published by ProPublica, a Pulitzer Prize-winning investigative newsroom. US inspectors have uncovered new and dangerous breakdowns in drugmaking at an Indian factory owned by Sun Pharma that produces generic medications for American consumers. The latest problems come 2 1/2 years after the Food and Drug Administration gave the facility a special pass to continue sending certain drugs made there to the United States, even after the factory was officially banned from the US market. The factory failed to investigate the source of bacteria found in test vials or deal with damaged equipment that had caused drugs to be contaminated with metal particles, according to the June inspection report, which ProPublica obtained through a Freedom of Information Act request. Workers improperly handled vials and stoppers meant for sterile medications and, in some cases, failed to disinfect manufacturing areas and equipment, according to the report. One FDA inspector saw a worker put on a sterile gown and then brush up against a waste bin and use their hands to push down the overflowing trash. Investigators also saw liquid dripping through ceiling cracks and the growth of what appeared to be fungus and mold in a storage area for samples used for testing. The FDA in late 2022 had banned the factory in the city of Halol from shipping drugs to the United States because of similar manufacturing failures. ProPublica reported last month that a low-profile group inside the agency at the same time exempted some medications from that ban, ostensibly to prevent drug shortages. The FDA has granted similar exemptions for drugs made at more than 20 other foreign factories that violated critical standards in drugmaking and were barred from the US market. The FDA kept the practice largely hidden from the public. The agency did not regularly test drugs coming from the banned factories or proactively monitor reports about potential harm among consumers, ProPublica found. In Sun's case, more than a dozen drugs were initially excluded from the Halol import ban. The company is still allowed to send five to the United States, government records show, including vecuronium bromide, a muscle relaxer used during surgery, and the cancer drug doxorubicin. Also excluded are divalproex delayed release tablets, which treat seizures and other conditions; leuprolide injection, used by people with prostate cancer, endometriosis and other conditions; and temozolomide capsules, for brain cancer. The inspection last month marked the first time the FDA had been back to the factory in the 2.5 years since it imposed the import ban and Sun started sending exempted drugs to the United States. Inspectors found that procedures designed to prevent microbiological contamination of sterile drugs were not established or followed and that equipment wasn't maintained to prevent malfunctions that would 'alter the safety, identity, strength, quality or purity of the drug product,' according to the report. Some of the concerns focused on the exempted drugs still being sent to the United States, according to a person familiar with the situation who did not want to be named because they were not authorized to speak publicly. The FDA blacked out the names of the drugs that were potentially compromised on its publicly released inspection report, including a medication made on a manufacturing line in which several batches had to be rejected because they were filled with black particles. 'It's disappointing to see issues continue to come up at this site given the site's role in potentially manufacturing critical drugs for US consumers,' said the person familiar with the inspection findings. Sun did not respond to questions about the latest inspection or its regulatory history with the FDA. In an email, the company said that adherence to quality standards 'is a top priority for Sun, and we maintain a relentless focus on quality and compliance to ensure the uninterrupted supply of medicines to our customers and patients worldwide. We continue to work proactively with the US FDA and remain committed to achieve full resolution of any FDA regulatory issues at our facilities.' The FDA said factories that receive exemptions from import bans are required to conduct extra testing on drugs with third-party oversight before they are sent to the United States, helping to ensure patient safety. Sun's Halol plant, however, was cited in 2022 and again last month for failing to thoroughly investigate unexplained quality problems, including impurities, found during drug testing. The FDA did not respond to a request for comment about the latest Sun inspection. US Rep. Debbie Dingell, D-Michigan, who recently co-sponsored a bill to lower prescription drug costs, said in a statement to ProPublica that the FDA has a responsibility to ensure that drugs coming into the country are safe. 'We need full transparency about the extent to which exemptions enabled sub-par, unsafe, or ineffective drugs to be distributed to American patients,' she said. Medill Investigative Lab student Katherine Dailey contributed reporting . Sign up to receive ProPublica's biggest stories as soon as they're published.
