Indian Manufacturer Faces Scrutiny Over Sanitation and Production Issues
November 17, 2023 – In a striking revelation, the U.S. Food and Drug Administration (FDA) has reported numerous sanitation and production issues at an Indian manufacturing plant responsible for producing a range of eye drops recently recalled in the United States. The factory in question, operated by Kilitch Healthcare India in Mumbai, has been under scrutiny following an FDA safety warning that affected over two dozen varieties of eye drops sold by major U.S. retailers like CVS Health, Target, and Rite Aid.
The concerning conditions at the plant were brought to light following an FDA inspection. Among the issues identified were employees working without proper protective gear, including masks, gloves, and gowns, with some even working barefoot in areas meant to be sterile. According to the FDA’s preliminary inspection report, a plant manager acknowledged that such practices were standard at the facility.
Further alarming observations included cracked floors and signs of deterioration on walls and ceilings, such as water stains and peeling paint. The FDA inspectors also uncovered evidence suggesting that the factory’s officials routinely manipulated or omitted contamination test results. For instance, instances where bacterial samples indicated potential contamination were not documented; instead, additional cleaning was conducted, and subsequent tests showing sterility were recorded.
Kilitch Healthcare has since issued a recall for the lubricating eye drops, encompassing 27 different brands and formulations. This recall followed an FDA alert to U.S. stores and consumers about the problem. Although the FDA lacks the legal authority to enforce drug recalls, they rely on manufacturers to voluntarily comply. In this case, the FDA had already recommended a recall and blocked imports from Kilitch prior to the official announcement.
Despite Kilitch Healthcare’s statement that no adverse events have been reported in relation to their products, the FDA has warned that the drops could potentially lead to vision loss or blindness. The recalled products, distributed in the U.S. by Velocity Pharma and carrying expiration dates through 2025, have raised serious concerns about the oversight of international pharmaceutical supply chains.
The FDA’s struggle to maintain safety standards for foreign products is not a new challenge, especially with the growing number of pharmaceutical supplies originating from India. The agency’s inspection activities were significantly hampered during the COVID-19 pandemic, with no inspections in India during fiscal year 2021 and a reduced number in fiscal 2023.
Retailers affected by the recall have taken steps to address the issue, with CVS Health already halting the sale of the cited eye drops and offering refunds to customers. However, other companies involved, such as Cardinal Health, have not responded to inquiries about the recalled products.
This incident follows a separate case earlier in the year, where an outbreak of drug-resistant bacteria in the U.S. was linked to eye drops from EzriCare and Delsam Pharma. In that instance, the CDC reported over 80 cases of eye infections, including instances of vision loss, eye removals, and deaths. Subsequent inspections of the manufacturing plant in India revealed significant deficiencies in the production and testing processes, including inadequate sterility measures.
For several years, many other eyecare products have been recalled due to safety including ReNu with Moistureloc, and several other brands. If you have been harmed by an eyecare product, you have limited time to file your claim for monetary compensation.
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