Global Pharma Healthcare, which recently recalled 50,000 bottles of eye drops in the US market, due to “microbial contamination” has now come under the American drug regulator’s scanner for its inability to ensure the sterility of its products. The manufacturer of eyedrops was recently linked to deaths and injuries in the US as the factory was reported to have lacked measures to assure the sterility of its products, US health inspectors said.
Multiple problems were reported by the USFDA officials in their preliminary inspection of the pharmaceutical company’s Tamil Nadu plant. The inspection was held from late February through early March.
It was found upon inspection that the company uses procedures that can’t actually ensure that its products are sterile, the FDA staff wrote.
The inspectors said in their report that the plant had used “a deficient manufacturing process” between December 2020 and April 2022. Products made in this period were shipped to the US later.
The eyedrops produced at the Tamil Nadu plant have been linked to 68 bacterial infections in the US, including three deaths and eight cases of vision loss. Four people have had their eyeballs surgically removed due to infection. The drops were recalled in February by two US distributors, EzriCare and Delsam Pharma, according to a report by the Associated Press.
The spread of the eye infection raises concern as the pathogen causing it appears to be resistant to traditionally prescribed antibiotics. The inspection appears to be the FDA’s first visit to the plant, the report by the news agency said, citing the pharma company’s records.