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. FDA inspectors found about a dozen problems with how Global Pharma Healthcare made and tested the drops. The FDA released its preliminary inspection report Monday. Recalled eyedrops made at the plant have been linked to 68 bacterial infections in the U.S., including three deaths and eight cases of vision loss. Four people have had to have their eyeballs surgically removed due to infection. The outbreak is considered particularly worrisome because the bacteria driving it is resistant to standard antibiotics.