Global Pharma: FDA claims Indian company linked to eye drop deaths violated US safety standards
FDA
The United State's top regulator has alleged that the Indian manufacturer of eye drops connected to three deaths and serious infections in the countryviolated a number of safety standards.
After visiting the Global Pharma plant in Chennai, India, the Food and Drug Administration (FDA) released a report last week. as reported by the BBC.After an FDA suggestion, the company recalled the drops in February.
The products' imports have also been stopped by the FDA.
The eye drops, manufactured in India by Global Pharma and imported into the US under the brand names EzriCare Artificial Tears and Delsam Pharma's Artificial Tears, were linked to a deadly outbreak of infections that were resistant to treatment.
The US Centers for Disease Control and Prevention (CDC) discovered 68 patients in 16 states in March who had a rare strain of Pseudomonas aeruginosa, which can lead to life-threatening infections, particularly in those with weakened immune systems. Prior to the most recent outbreak, the drug-resistant strain has never been discovered in the nation.
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According to a March report from the BBC, eight people lost their vision, and four had their eyes surgically removed.
"To the greatest extent possible, we have been contacting customers to advise them against continued use of the product," EzriCare Artificial Tearssaid on its websitein February.
The company claimed that while it promoted the eye drops, it played no part in the "actual manufacturing" of the products.
The Delsam Pharma eye ointment was later added to the product recall, which was originally restricted to the eye drops EzriCare Artificial Tears Lubricant and Delsam Pharma Artificial Tears Lubricant.
The Global Pharma plant in India was inspected by the FDA for 11 days starting on February 20. The FDA noted multiple sterilisation and hygiene violations in its report.
The FDA report also notedthat surfaces that came into contact with the drug packaging "were not cleaned, sanitised, decontaminated, or sterilised".
Many Indian companies have recently come under fire for the quality of their pharmaceutical products, with experts voicing worries about the manufacturing procedures used to create these medicines.
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