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.
Inspectors arrived at the plant Feb. 20, more than two weeks after the announcement of the first eyedrop recall on Feb. 3. The inspection appears to be the FDA’s first visit to the plant, according to agency records.
“We urge consumers to stop using these products which may be harmful to their health,” FDA’s Jeremy Khan wrote in an emailed statement. 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. Instead, a “manual visual inspection is the only test to detect any leak,” according to the report.
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