Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated, according to a Food and Drug Administration inspection report obtained by STAT.
During a recent visit to the facility in Tamil Nadu, India, agency inspectors found the company failed to take basic steps during sterilization, relied on deficient manufacturing processes and methods to ensure and verify sterility, and did not have adequate systems to create aseptic conditions, among other issues.
The FDA inspected the plant over 10 days in late February and early March, not long after the company began recalling its eye drops over concerns about contamination, the inspection report noted. At the time of the Feb. 2 recall announcement, the agency reported a growing number of people who suffered eye infections or permanent vision loss, as well as a death involving a bloodstream infection.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.
Already have an account? Log in
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect