According to U.S. health inspectors, the maker of eyedrops recently connected to deaths 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, the FDA disclosed the results of its initial examination.
FDA personnel 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.”
Three deaths and eight cases of vision loss have been associated with the plant in India’s southern Tamil Nadu state, which produced eyedrops that were linked to 68 bacterial infections in the United States.
Due to infection, the eyeballs of four persons had to be surgically removed. EzriCare and Delsam Phama, two U.S. distributors, recalled the drops in February.
The outbreak is considered particularly worrisome because the bacteria driving it is resistant to standard antibiotics.
Inspectors arrived at the plant Feb. 20, more than two weeks after the announcement of the first eyedrop recall on Feb. 3. The inspection appears to be the FDA’s first visit to the plant, according to agency records.
The report has the agency’s preliminary findings and is likely to be followed by a formal report and a warning letter to the company. An FDA spokesman said the inspection indicates that the company’s products “may be in violation of FDA’s requirements.”
“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 responsible for assuring the safety of foreign products shipped to the U.S., though it has long struggled to keep pace with international pharmaceutical supply chains that increasingly begin in India and China.
FDA inspectors cited worrisome sanitary conditions at the Global Pharma plant, noting that its floors, walls and ceilings were not “easily cleanable.” At one point during the visit, an FDA inspector noted “none of the equipment on the filling machine was wrapped or covered.”
The inspector also noted the company didn’t have rigorous procedures for ensuring bottles were fully sealed. Instead, a “manual visual inspection is the only test to detect any leak,” according to the report.
Global Pharma has said little publicly about its recent recalls, instead referring questions to the U.S. companies that sold the products.
The FDA has been investigating the U.S. bacterial infections alongside the Centers for Disease Control and Prevention. CDC officials have detected the bacterial strain in opened bottles of EzriCare drops collected from infected patients. FDA officials are also testing unopened bottles of the drops.
CDC officials are worried the bacteria will spread and cases may be reported for weeks and months to come. The agency has been urging health care facilities treating patients to follow strict infection-control recommendations because the germ can spread rapidly.