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 U.S. Food and Drug Administration inspection report obtained by STAT.
During a recent visit to the facility in Tamilnadu, 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.
