The eye drop maker that has been linked to an outbreak of serious bacterial infections in the US, 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 due to possible contamination.
At the time of withdrawal, there were 55 reports of adverse events, including eye infections, permanent vision loss, and at least one death from bloodstream infection. From end of last month68 infections had been identified in 16 states, according to the US Centers for Disease Control and Prevention. There have been three deaths, eight cases of vision loss and four surgical eye removals.
An 11-day inspection of Global Pharma facilities resulted in 11 observations by the FDA, including a “manufacturing process that lacked assurance of product sterility,” specifically for batches of products that were manufactured between December 2020 and April 2022 and shipped to the US.
The EzriCare Artificial Tears product, manufactured by Global Pharma, is part of an outbreak of infections by bacteria called Pseudomonas aeruginosa.
This rare, drug-resistant bacteria can spread between people who don’t have symptoms and between 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 items or when health workers transmit the germs, which is why infection control is as important as hygiene of the hands,” the agency told CNN in an email. Monday.
Several cases in the current outbreak have been identified in people carrying the bacteria without signs or symptoms of clinical infections, the CDC said. These cases were discovered through examinations at inpatient health care facilities that had clusters of infections.
The particular strain of bacteria associated with this outbreak has never before been reported in the US, and related infections have been identified in acute care hospitals, long-term care facilities, emergency departments, urgent care clinics and other outpatient facilities.
People affected by the outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears was the most common.
The FDA inspection of Global Pharma facilities is part of an ongoing compliance matter.
“The FDA’s top priority is protecting public health; this 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 that recall these affected products. We urge consumers to stop using these products that may be harmful to their health.”