Manufacturer Of Eyedrops Connected To Deadly Infections Couldn't Ensure Factory Was Sterile, Says FDA

U.S. health inspectors found that the manufacturer of eyedrops recently connected to fatalities and injuries lacked safeguards to ensure sterility at its facilities in India.

During an inspection from late February through early March, representatives of the Food and Drug Administration discovered roughly a dozen issues with the production and testing of Global Pharma Healthcare's eyedrops. On Monday, Apr. 3, the FDA disclosed the results of its initial examination.

FDA staff wrote that the corporation uses processes that cannot genuinely guarantee the sterility of its products.

The inspectors discovered, in particular, that between December 2020 and April 2022, the plant produced goods that were eventually transferred to the United States using "a deficient manufacturing process."

The plant in India's southern Tamil Nadu state produced eyedrops that have been linked to 68 bacterial infections in the U.S., including three deaths and eight cases of vision loss. Four people have had their eyeballs surgically removed due to infection.

The drops were recalled in February by two U.S. distributors, EzriCare and Delsam Pharma, NBC News reported.

Given that the bacteria causing the outbreak are resistant to common antibiotics, the outbreak is regarded as being extremely concerning.

Inspectors visited the facility on Feb. 20, more than two weeks after the first eyedrop recall was announced on Feb. 3. According to agency records, the inspection appeared to be the FDA's first trip to the plant.

The agency's preliminary conclusions are included in the report, which will probably be followed by a formal report and a letter of caution to the corporation.

The examination suggests that the company's products "may be in violation of FDA requirements," according to an FDA representative.

"We urge consumers to stop using these products which may be harmful to their health," FDA's Jeremy Khan wrote in an emailed statement.

The FDA is in charge of ensuring the security of imports into the United States, but it has long struggled to keep up with global pharmaceutical supply chains that increasingly originate in China and India.

The Global Pharma plant's flooring, walls, and ceilings were not "easily cleanable," according to FDA inspectors, who also noted other concerning sanitary conditions there.

An FDA inspector made the observation that "none of the equipment on the filling machine was wrapped or covered" at one point during the visit.

The inspector also observed that the business lacked strict protocols to guarantee that bottles were completely sealed. The report claims that a "manual visual inspection is the only test to detect any leak."

Global Pharma has said little publicly about its recent recalls, instead referring questions to the U.S. companies that sold the products.

Along with the Centers for Disease Control and Prevention, the FDA has been looking into bacterial infections in the United States.

The bacterial strain was found by the CDC in opened EzriCare drop bottles that were taken from infected individuals. FDA officials are also testing unopened bottles of the drops.

Officials at the CDC are concerned that the infection may spread and that cases may continue to be reported for weeks or months.

Because the bacterium can spread quickly, the agency has been urging healthcare facilities treating patients to adhere strictly to infection-control standards.