The FDA says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops.
WASHINGTON — The manufacturer of eyedrops recently linked to deaths and injuries lacked measures to assure sterility at its factory in India, according to U.S. health inspectors.
The plant in India's southern Tamil Nadu state produced eyedrops that have been linked to 68 bacterial infections in the U.S., 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 U.S. distributors, EzriCare and Delsam Pharma.
The report has the agency's preliminary findings and is likely to be followed by a formal report and a warning letter to the company. An FDA spokesman said the inspection indicates that the company's products "may be in violation of FDA's requirements." FDA inspectors cited worrisome sanitary conditions at the Global Pharma plant, noting that its floors, walls and ceilings were not "easily cleanable." At one point during the visit, an FDA inspector noted "none of the equipment on the filling machine was wrapped or covered." The inspector also noted the company didn't have rigorous procedures for ensuring bottles were fully sealed.
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Eyedrops maker couldn't ensure factory was sterile, FDA saysThe Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops
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Eyedrops maker couldn't ensure factory was sterile, FDA saysThe Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops.
Read more »