FDA Finds Dozens Of Issues At Eye Drops Factory In India Tied To Outbreak

Inspectors with the Food and Drug Administration detailed dozens of problems at an eye drops manufacturing plant tied to a fatal outbreak of drug-resistant bacteria. It was the first time that the strain of bacteria has been seen in the United States. While it initially infected people who used the eye drops, it can also be spread from person to person.

The outbreak has been linked to at least three deaths and caused at least eight people to lose their vision.

The FDA conducted a surprise inspection at the Global Pharma Healthcare Pvt Ltd. plant in India on February 20, several weeks after a recall of the company's EzriCare Artificial Tears and Delsam Pharma's Artificial Eye Ointment. Inspectors spent over a week at the plant and issued a scathing report about what they discovered.

The 14-page report details 11 observations made by the inspectors, which include poor cleaning procedures for equipment and a lack of proper training for workers. In addition, the plant failed to conduct important tests to ensure that products were sterile before they were shipped out and never tested ingredients procured from outside suppliers.

The FDA has banned all imports of eyedrops made a the factory.

Global Pharma has not commented on the report.