FDA Finds Sterility Issues at Eyedrops Manufacturer Linked to Deaths and Outbreaks

The FDA has released a preliminary inspection report stating that the manufacturer of eyedrops, Global Pharma Healthcare, lacked measures to ensure sterility at its factory in India. The plant produced eyedrops that have been linked to 68 bacterial infections in the US, including three deaths and eight cases of vision loss. The FDA inspectors found about a dozen problems with how the company made and tested its eyedrops, including a deficient manufacturing process that was used between December 2020 and April 2022. The FDA is responsible for assuring the safety of foreign products shipped to the US, but it has long struggled to keep pace with international pharmaceutical supply chains that increasingly begin in India and China.