SILVER SPRING, Md.—Global Pharma Healthcare, the India-based manufacturer of eye drops that have been linked to an outbreak of bacterial infections in the U.S., including at least three deaths, failed to follow proper protocol to prevent contamination of its products, according to a Food and Drug Administration (FDA) inspection report. The FDA inspection of the Global Pharma facility is part of an ongoing compliance matter. The 14-page report detailed violations of the FDA’s 11-day facility inspection in India that started after the company recalled EzriCare Artificial Tears due to possible contamination.

The recall was demanded by the FDA after its initial requests of two other products linked to the company as reported by VMAIL. The inspection resulted in 11 observations by the FDA, including 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 U.S.

The violations included there being no mention of the cleaning of several parts of the “sterile manufacturing area” in the cleaning record.

 
The EzriCare Artificial Tears product, which is manufactured by Global Pharma, is part of an outbreak of infections from bacteria called Pseudomonas aeruginosa. This rare drug-resistant bacteria can spread among people who don’t have symptoms and to people who haven’t used the eye drops, according to the Centers for Disease Control and Prevention (CDC). The particular strain of the bacteria associated with this outbreak had never before been reported in the U.S.

In disputing the FDA’s findings, India’s federal health ministry has said no contamination was found in samples of eye drops made by the pharma firm. The samples were found to be of “standard quality”, according to a report from NDTV.com.