Dirty equipment and sterilization issues are among the many violations found by the FDA.
The US Food and Drug Administration conducted an inspection of a Global Pharma Healthcare facility in India recently. The company is the maker of EzriCare Artificial Tears, which was recalled in early February and has since resulted in 3 deaths, 8 reports of permanent vision loss, and 4 reports of enucleation.
According to inspection records released by the FDA1, federal inspectors visited the site in mid-February and found dozens of issues. These included dirty equipment and clothing as well as missing safeguards and procedures.
The FDA issued 11 observations of the Global Pharma Facility over its 11-day inspection. This could possibly be the first visit from the FDA to this site as no other visits are on record. The FDA stated inspectors had found a “manufacturing process that lacked assurance of product sterility,” specifically for batches of product that were manufactured between December 2020 and April 2022 and shipped to the US.
Among the issues, the FDA's inspectors say they found evidence of poor cleaning procedures throughout the facility and gaps in written procedures and training for workers at the plant.
Booties being used in the company's cleanrooms were observed to be "discolored, and worn-out." The company "did not track or have studies to show how many times" clothing could be reused by workers.
An inspector noted seeing "a black, brown greasy deposit" on part of one of the company's machines to fill its product into bottles. Logs from the company claimed the machine had been cleaned just weeks before and had not been used since.
FDA inspectors also noted that key tests to double check the products coming off the lines were sterile were never done, while others that had been had never been validated.
The company also did not double-check the ingredients it used in its products, relying on assurances from its suppliers instead, according to the FDA.
"Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals," the inspectors wrote in their report.
As previously reported, the CDC has stated that the bacteria can spread among people who don’t have symptoms and even to people who haven’t even used the eye drops.
An official from the CDC told CNN, “The bacteria can spread when 1 patient carrying the bacteria exposes another patient, or when patients touch common items or when healthcare workers transmit the germs which is why infection control, like hand hygiene, is so important.”
According to the CDC, several cases in the current outbreak have been identified in people who were carrying the bacteria without signs or symptoms of clinical infections. These cases were discovered through screenings at inpatient health care facilities that had clusters of infections.
“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 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 recalling these affected products. We urge consumers to stop using these products which may be harmful to their health.”