US inspectors have discovered new and dangerous breakdowns at an Indian factory owned by Sun Pharma, which produces common medicines for US consumers.
Recent problems arise after 2 1/2 years after the nutrition and medicine management gave the facility a special pass to continue to send certain drugs made there in the US, even after the plant was officially banned in the US market.
The factory was unable to explore the source of bacteria in test vials or in the fight against damaged equipment that caused the pollution, according to the metal particles, according to In a June report on inspectionwhich propublica is obtained through a request for the Liberty Law.
In the report, the employees incorrectly handled vials and stops intended for sterile medicines, and in some cases were unable to disinfect production areas and equipment. One FDA inspector saw that the worker had put on a sterile dress and then pressed against the debris and used their hands to push off overflowing garbage. Investigators also saw the fluid pass through the cracks of the ceiling, and the growth of what seemed like a mushroom and mold in the storage area for samples used for testing.
At the end of 2022, the FDA banned a plant in the city of drug delivery to the US because of similar production failures.
PROPUBLICA reports last month What a low -profile group inside the agency simultaneously released some medicines from this ban, allegedly to prevent drug deficiency. The FDA has provided similar exceptions to drugs made at more than 20 other foreign factories that violated critical standards in drug production and were banned from the US market.
The FDA kept the practice largely hidden from the public. Papublitsa found that the agency did not regularly check the drugs coming from the prohibited factories and actively monitor the potential damage reports.
In the case of the sun, more than a dozen drugs were initially excluded from the ban on importing halo. Companies are still allowed to send five to the US, Show state recordsIncluding Bromide Vercuronia, the muscular relaxer used during surgery, and doxarubicine cancer. Divalproex tablets are also excluded that treat attacks and other conditions; Liprolid injection used by people with prostate cancer, endometriosis and other conditions; and capsules thezolamide, for brain cancer.
Last month, the inspection noted that the FDA returned to the factory for 2.5 years, as imposed on imports, and the sun began to send drugs released to the United States. Inspectors found that the procedures designed to prevent microbiological contamination of sterile drugs are not installed or performed, and that the equipment was not stored to prevent malfunctions that “change the safety, identity, strength, quality and purity of addiction,” the statement said.
Some problems focused on the released drugs still go to the United States, according to a person familiar with a situation that did not want to call because they had no right to talk publicly. Fda darkened drug names What were potentially compromised in his publicly released report on the inspection, including the medicines made on the production line, which had to reject several parties because they were filled with black particles.
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Received propublica
“It is disappointing to see how the questions continue to arise on this site, given the role of the site in potentially making important drugs for US consumers,” said a man acquainted with the check out.
The sun did not answer questions about the latest inspection or its normative history with the FDA. In the email, the company stated that maintaining quality standards “is a top priority for Sun, and we support the tireless emphasis on quality and preservation to provide continuous supplies for our customers and patients around the world. We continue to work actively with the US FDA and remain committed to reaching the full solution of any FDA regulation problems.”
The FDA has stated that factories receiving exceptions from import ban should conduct additional drug testing with other supervision before sending them to the US, helping to ensure the safety of patients. However, the Sun Halol plant was given in 2022 and again last month for not carefully exploring the inexplicable quality problems, including impurities found during drug testing. The FDA did not respond to a comment on the latest sun inspection.
US representative Debbie Dingel, D-Michigan, who recently co -authored the bill To reduce the costs of prescription medication, a propublica said in a statement that the FDA is responsible for drug safety to the country.
“We need complete transparency in the extent to which release allows you to spread to the base, dangerous or ineffective drugs,” she said.
Medil Lab student Catherine Dale reported.
