CNN —
The maker of eyedrops, which has been linked to an outbreak of serious bacterial infections in the United States, including at least three deaths, failed to follow proper protocol to prevent contamination of its products, according to an inspection report released Friday by the US Food and Drug Administration .
The FDA visited a Global Pharma Healthcare facility in India for an inspection that began in mid-February, two and a half weeks after the company recalled EzriCare Artificial Tears over possible contamination.
At the time of the recall, there were 55 reports of adverse events, including eye infections, permanent vision loss, and at least one death with a bloodstream infection. By the end of last month, 68 infections had been identified in 16 states, according to the US Centers for Disease Control and Prevention. Three deaths, eight cases of vision loss and four surgical eye removals were reported.
An 11-day inspection of Global Pharma’s facility resulted in 11 observations from the FDA, including a “manufacturing process that did not ensure product sterility,” specifically for product lots manufactured and shipped to the United States between December 2020 and April 2022.
The EzriCare Artificial Tears product, manufactured by Global Pharma, is part of an outbreak of infections caused by a bacteria called Pseudomonas aeruginosa.
This rare drug-resistant bacterium can spread among people who don’t have symptoms — and among people who haven’t used the eye drops, according to the CDC. This type of spread is particularly common in healthcare settings.
“The bacteria can spread when a patient who carries the bacteria exposes another patient, or when patients touch common objects, or when medical workers transmit the germs, which is why infection control like hand hygiene is so important,” the agency told CNN in an email Monday.
Several cases of the current outbreak have been identified in people who carried the bacteria with no signs or symptoms of clinical infections, the CDC said. These cases were discovered through screenings at inpatient healthcare facilities that showed clusters of infection.
The particular strain of bacteria associated with this outbreak had never been previously reported in the United States, and related infections have been identified in acute care hospitals, long-term care facilities, emergency rooms, emergency departments, and other outpatient settings.
People affected by the outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears was the most commonly reported.
The FDA inspection of Global Pharma’s facility is part of an ongoing compliance matter.
“The FDA’s top priority is protecting public health — which includes working with manufacturers to quickly remove unsafe drugs from shelves when they are identified,” the agency said in an email Monday. “The FDA continues to monitor this issue and is working with the Centers for Disease Control and Prevention (CDC) and the companies recalling these affected products. We urge consumers to stop using these products as they could be harmful to their health.”