Title: FDA Reveals Manufacturing Violations at Indian Facility Producing Generic Eye Drops
By KP INSIDER
In a recent FDA inspection report, a manufacturing facility in India that produces generic eye drops for well-known brand names and store brands was found to be in violation of several critical regulations. The violations were uncovered following an FDA warning to consumers last month, urging them to stop using over 24 kinds of eye drops sold under various big-brand names and store brands due to the risk of infection.
Kilitch Healthcare India Limited, located in Mumbai, is responsible for manufacturing all the affected products, which include eye drops sold under CVS, Target, Rite Aid, Walmart, Leader, Rugby, and Velocity Pharma brands. Although no infections have been linked to the eye drops so far, major retailers have taken prompt action and removed the products from their shelves.
Upon inspection, the FDA report outlined 14 categories of manufacturing problems, ranging from documentation and laboratory controls to sanitation and testing protocols. The inspection also revealed that the facility itself was in poor condition, with cracked floors, peeling paint, water stains, and dust build-up.
One of the most concerning violations was the discovery that workers in the sterile area of the facility were observed working barefoot and without appropriate protective gear, such as gowns and gloves. Astonishingly, the production manager defended this practice as “standard.”
Further, the inspection report highlighted a failure to document bacterial contamination. Rather than recording and addressing the contamination, the facility had been discarding the results until the contamination level fell below the alert threshold. While the facility’s microbiology laboratory had reportedly reported no action-level results in the past five years, the FDA inspection found 39 alert- and action-level detections.
As a result of the FDA warning, Kilitch Healthcare India Limited issued a voluntary recall of the affected products. This incident adds to a series of concerning events related to eye drops, including an outbreak of drug-resistant bacterial infections and non-sterility concerns surrounding other eye drop products.
Consumers are advised to exercise caution and check for recall information before purchasing any eye drop products. The FDA continues to monitor the situation and urges anyone experiencing adverse effects from the use of eye drops to consult a healthcare professional immediately.
Given the potential risks linked to the manufacturing violations at the Indian facility, it is crucial for consumers to remain vigilant and prioritize their eye health and safety.