The Food and Drug Administration has revealed that the maker of a brand of eye drops linked to an outbreak of fatal bacterial infections failed to follow multiple safety protocols.
The FDA visited a Global Pharma Healthcare facility in India for an inspection in mid-February and found dozens of issues ranging from dirty equipment and clothing to missing safeguards and procedures.
The inspection came two-and-a-half weeks after the company voluntarily recalled the EzriCare artificial tears product because of possible contamination.
When the recall was issued, there were already 55 reports of adverse events, including eye infections, permanent loss of vision, and at least one death from a bloodstream infection.