
According to a recent AP article, Indian manufacturer Kilitch Healthcare India, responsible for the recalled eyedrops sold in the U.S., faces significant sanitation and manufacturing issues, including barefoot workers, cracked floors, and altered records. A preliminary inspection report by the U.S. FDA revealed numerous problems at the Mumbai plant, which produced over two dozen eyedrop varieties subject to an FDA safety warning.
Inspectors found workers not wearing appropriate protective gear, cracked floors, water stains, and peeling paint, along with routine omission or falsification of contamination test results; the FDA's initial findings are expected to be followed by a formal report and a warning letter, while Kilitch Healthcare has officially recalled the eyedrops, previously sold by major retailers.