The FDA visited the facility, located in India, in mid-February — two and a half weeks after recalling the first of three artificial tears products manufactured by Global Pharma Healthcare Private Limited.
During the 11-day inspection, the FDA made 11 concerning observations, including “manufacturing process that lacked assurance of product sterility,” specifically for batches of product manufactured between December 2020 and April 2022.
“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. “The FDA continues to monitor this issue and is working with the CDC and the companies recalling these affected products. We urge consumers to stop using these products which may be harmful to their health.”
The CDC said 68 people in 16 states have reported complications after using the eye drops; there have been three deaths, eight cases of blindness and four surgeries involving removal of an eyeball and dozens of eye infections reported. Because the bacteria spreads among humans, the agency warned the bacteria “could gain a foothold in the U.S.”
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