Eyedrops maker couldn't ensure factory was sterile, FDA says

 


WASHINGTON (AP) — 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.

Food and Drug Administration officials uncovered about a dozen problems with how Global Pharma Healthcare made and tested its eyedrops during an inspection from late February through early March. The FDA released its preliminary inspection report Monday.

The company uses procedures that can't actually ensure its products are sterile, FDA staff wrote. In particular, the inspectors found that the plant had used "a...



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