The eyedrop maker recently linked to deaths and injuries lacked measures to ensure sterility at its factory in India, according to US health inspectors.
Food and Drug Administration officials discovered about a dozen problems with the way Global Pharma Healthcare made and tested its eye drops during an inspection from late February to early March. The FDA released its preliminary inspection report on Monday.
The company uses procedures that cannot actually guarantee that its products are sterile, the FDA staff wrote. In particular, inspectors found that the plant had used "a poor manufacturing process" between December 2020 and April 2022 for products that were later shipped to the US.
The plant in the southern Indian state of Tamil Nadu produces eye drops that have been linked to 68 bacterial infections in the US, including three deaths and eight cases of vision loss. Four people had their eyeballs surgically removed due to infection. The drops were recalled in February by two US distributors, EzriCare and Delsam Phama.
The outbreak is considered particularly worrying because the bacteria causing it are resistant to standard antibiotics.
Inspectors arrived at the plant on February 20, more than two weeks after the announcement of the recall of the first eye drops on February 3. The inspection appears to be the FDA's first visit to the plant, according to agency records.
The report contains the agency's preliminary findings and is likely to be followed by a formal report and warning letter to the company. An FDA spokesperson said the inspection indicates the company's products "may be in violation of FDA requirements."
“We urge consumers to stop using these products that may be harmful to their health,” the FDA's Jeremy Khan wrote in an emailed statement.
The FDA is responsible for ensuring the safety of foreign products shipped to the US, though it has long struggled to keep pace with international pharmaceutical supply chains that increasingly start in India and China.
FDA inspectors cited concerning sanitary conditions at the Global Pharma plant, noting that its floors, walls, and ceilings were not "easy to clean." At one point during the visit, an FDA inspector noted that "none of the filling machine equipment was wrapped or covered." The inspector also pointed out that the company did not have rigorous procedures to ensure that the bottles were completely sealed. Instead, a “manual visual inspection is the only test for any leaks,” according to the report.
Global Pharma has said little publicly about its recent recalls, instead referring questions to the US companies that sold the products.
The FDA has been investigating bacterial infections in the US in conjunction with the Centers for Disease Control and Prevention. CDC officials 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 concerned that the bacteria will spread and cases may be reported over the next few weeks and months. The agency has been urging health care facilities that treat patients to follow strict infection control recommendations because the germ can spread quickly.