Nutrition and medicine administration is cleared of a common drug manufacturer, which was the subject of PROPBLICA investigation last year, citing problems with the security tests that delayed the recall
In December, Propublica reported that the Glenmar Pharmaceuticals plant in Central India is responsible for A negative share of the pill recalls This is not dissolved properly and can harm American patients. Among a number of recalls, federal regulators have determined that more than 50 million potassium -sold potassium capsules sold in the US sold in the US May be deadly. However, federal drug inspectors have not been stepping at the Madzha -Prades factory for more than four years at this point, Popublica has discovered.
Seven weeks after the publication of the story, FDA inspectors appeared at the factory and found serious problems. Glenmark after reminded of two more dozen medicines Made there and sold to us to patients.
Now FDA has sent Glenmark preventionThe disciplinary tool that the regulator uses to teach significant violations of federal requirements and changes in demand. If Glenmark does not correct any issued problems, warned FDA, it can forbid drugs made at the factory from entering the US
Moreover, the FDA noted that the company made similar mistakes at the other three production sites and acknowledged that these factories were the subject of previous agency’s pre -warning letters. The problems in one were so serious that the federal regulators blocked the drugs that they had been imported from the Americans. In December, the Prapublica investigation emphasized this picture, noting that three of the five factories where Glenmark created drugs for the US market in recent years faced federal regulators. Despite the fact that the FDA – FDA – gave up the pandemic – waited five years before sending its inspectors back to the Madzha -Prades plant.
In his warning, on July 11, the Director of the FDA Production Department wrote: “These repeated failures on several sites show that control and control over drug production is not enough.” (Agency made a letter to Publiclast Week.)
“You must immediately and comprehensively evaluate the global production operations of your company to provide systems, processes and products that are manufactured in accordance with the FDA requirements,” he added.
The company’s press secretary said in a written statement: “Glenmark actively interacts with the US FDA and initiated corrective actions to resolve the agency’s observations. Patient security, product quality and regulation are major for how we work.”
Referring to the company’s permanent lawsuits, she refused to comment on.
PROPUBLICA conducted an investigation a Supervision of foreign factories FDA which make common drugs for the American market.
Since last year, Propublica has repeatedly asked the FDA why he did not send inspectors to the Glenmark factory before, given the negative share of the company’s revocations and problem services at his other factories. The agency did not answer the question. After the inspection problem came this year, the FDA press -secretary said that the agency could only discuss potential or constant issues on compliance with the company’s participation.
Among the most serious violations stated in the FDA’s letter to Glenmark, there was an inability of the company to promptly test the pills to make sure that they are properly dissolved during the usual storage period, the propublica investigation into last year.
Companies hold samples of pills from the parties sold to us by customers, and periodically check them until they reach the expiration date. Medicines that do not dissolve properly can cause dangerous changes when dosing. This downside is something that has made potassium chloride pills potentially deadly because high potassium levels Can stop the heartAccording to June 2024, the message is recalled.
Laundered Glenmark testing was overdue for 3 months and a larger share of your samples, “the FDA wrote in a warning. Failure to comply with these tests caused the opening of defective tablets Glenmark and delayed the necessary recalls, the agency reports.
In several cases, the FDA found that 100 days have passed since Glenmark pulled potassium chloride samples until the company had learned that the capsules had failed to dissolve properly.
The delay in this recall may come in a lawsuit claiming that potassium chloride pills were responsible for death last year by Mary Louise Cormie, 91-year-old Meng. A letter that warns the feed that her pills were recalled three weeks after she died. Glenmark denied responsibility for her death in court statements. The company has stopped doing drugs for patients with the United States.
Between July to December last year, Glenmark said FDA that she received reports of eight deaths in patients who took the recalled potassium chloride, shows federal records. The reports that companies should submit to the FDA can control the drug safety, contained so few details that the propublica could not independently check what happened in each case. In general, these side -events reports reflect the opinions of those who have submitted them and does not prove that the drug has caused damage, the FDA says. The agency did not mention these deaths in the warning.
The FDA fastened Glenmark for not carefully exploring why the pills made at its Madzha -Prades factory were not properly dissolved. The agency listed the possible reasons why Glenmark did not take into account, but the FDA censorship edited so many passages – citing commercial secrets and confidential business information – which cannot be understood that it can go wrong.
Referring to the same confidentiality provision, the FDA retained the secret of the name of another drug Glenmark, which, according to the agency, did not receive the same tests. Asked why consumers should not say what medicines had problems, the FDA did not answer.
To a greater extent, the FDA warned criticized Glenmark for not confirming the tests on which it rests to prove that his drugs have identity, strength, quality and purity they should have.
“Without assessing the validity of the methods, you lack the basic confidence that your laboratory data accurately reflects the quality of drug products,” the FDA wrote.
