(CNN) -- The manufacturer of eye drops that have been linked to an outbreak of serious bacterial infections in the US, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report published Friday by the US Food and Drug Administration.
The FDA visited a Global Pharma Healthcare facility in India for an inspection that started in mid-February, two and a half weeks after the company had voluntarily recalled the EzriCare Artificial Tears product due to possible contamination. At the time of the recall, there were already 55 reports of adverse events including eye infections, permanent loss of vision and at least one death with a bloodstream infection.
An 11-day inspection resulted in 11 observations by the FDA, including a "manufacturing process that lacked assurance of product sterility," specifically for batches of product that were manufactured between December 2020 and April 2022 and shipped to the US.
EzriCare Artificial Tears product, which is manufactured by Global Pharma Healthcare, is part of an outbreak of a rare and drug-resistant bacteria called Pseudomonas aeruginosa. The particular strain of the bacteria associated with this outbreak had never before been reported in the US. Patients affected by the outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears was most commonly reported.
The FDA inspection of the Global Pharma Healthcare facility is part of an ongoing compliance matter.
"The FDA's highest priority is protecting public health -- this includes working with manufacturers to quickly remove unsafe drugs from shelves when they are identified," the agency told CNN in an email on 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 which may be harmful to their health."
