12/25/2023 0 Comments Shipit delete accountSometimes there’s a lag between an FDA inspection and an export prohibition. However, not every red flag in an inspection results in a warning letter, meaning the full extent of violations may not be publicly available. Warning letters are public and don’t require a Freedom of Information Act request. With about 600 FDA-registered factories in India, that makes it difficult to get a snapshot of data integrity across the entire industry. The FDA told Bloomberg it could only handle requests for four inspection documents, known as Form 483s, at a time without making the process lengthier and more complicated. Caraco representatives didn’t return phone messages. It’s unclear whether the Detroit plant and the India plant processed the same products.Ībout 22 million prescriptions of cephalexin, which is made by several generic companies, are written each year in the US, according to data compiled by Bloomberg. The active ingredient made by Sun wasn’t produced using good manufacturing practices, the FDA said in an enforcement report in August, without providing details. Three years after the incident highlighted by the FDA, Sun’s Caraco Pharmaceutical Laboratories Ltd in Detroit recalled 450,000 bottles of cephalexin, a type of cephalosporin. The plant near Vadodara was approved to make generic cephalosporin, a class of a popular antibiotic. Sun Pharma has 25 manufacturing facilities worldwide, including 11 in India and seven in the US. This year, the FDA had conducted 97 inspections of drug manufacturers as of the end of October, said Tara Goodin, an agency spokeswoman. The agency has about a dozen staff members in India to police about 600 factories registered there with the US. The FDA relies on factories themselves to conduct quality tests and report accurate results, only performing its own studies if it gets enough complaints about a medicine. The US doesn’t require tests of imported drugs as they cross the border. The top 10 pharmaceutical companies based in the country generate $15 billion in annual sales, according to data compiled by Bloomberg. India is the second largest drug exporter to the US, and companies there mainly produce generic drugs and active ingredients for medicine. since last year-many of which supplied Americans’ most vital medicines-are accused of failing to report data from tests that were supposed to confirm the drugs were safe and would work. “If they make multiple batches, does it come out the same, with the same amount of drug in it? And when you give it to a patient, can you assume it will work consistently?" said Harry Lever, a cardiologist at the Cleveland Clinic.Ī review of inspection documents and warning letters shows that at least 12 drug companies with Indian facilities banned from sending pharmaceutical products to the U.S. They say they fear prescribing generic drugs that may not do what they’re supposed to. While not as visible as the dead frogs and flies inspectors have found in other Indian labs, the pattern of data integrity breaches worries doctors in the US and elsewhere. A review of FDA documents by Bloomberg News found that similar actions on quality tests have happened at dozens of other companies’ plants across India that make drug ingredients and pills for export to the US. Frederick Castro, a spokesman for Sun Pharma, declined to comment. The name of the drug or ingredient that the company was testing was redacted in documents Bloomberg obtained from the FDA under a Freedom of Information Act request. Two months earlier, the agency had banned imports from the plant, near Vadodara. The incident “raises concerns about the integrity of all data generated by your firm", the FDA wrote in a separate warning letter to Sun Pharma in May. “Our review found that analysts regularly delete undesirable chromatographic results, and products are re-tested without initiating an investigation as required," inspectors wrote in the document.
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