Eyedrops maker couldn't ensure factory was sterile, FDA says
The Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops WASHINGTON -- The manufacturer of eye drops 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 Health care made and tested its eye drops 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 deficient manufacturing process” between December 2020 and April 2022 for products that were later shipped to the U.S. The plant in India's southern Tamil Nadu state produced eyedrops that have been linked to 68 bacterial infections in the U.S., includi...