Barefoot workers and cracked floors were found at a factory that made recalled eyedrops, FDA says

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The Food and Drug Administration (FDA) has exposed a series of alarming issues at a Mumbai-based factory operated by Kilitch Healthcare India, the Indian company responsible for the recent recall of eye drops sold in the United States. These problems range from unsanitary conditions to record tampering. The factory manufactured over two dozen types of eye drops that were previously subjected to an FDA safety warning.

Among the concerning findings during the FDA inspection were:

1. Unhygienic Practices: Factory workers were observed not wearing protective gear like masks, gloves, and gowns, and some even worked barefoot in areas that should have been sterile. Shockingly, a manager claimed that this was standard practice.

2. Infrastructure Problems: The facility exhibited structural issues, including cracked floors and visible water stains and peeling paint on walls and ceilings.

3. Contamination Test Manipulation: Factory officials were found to routinely omit or falsify contamination test results. For instance, bacterial samples that could trigger an alert or action limit were not documented. Instead, additional cleaning would occur, and a sterility figure would be recorded. This fraudulent practice reportedly happened multiple times per month.

The FDA’s initial findings will likely lead to a formal report and a warning letter being issued to Kilitch Healthcare. The company officially recalled the lubricating eye drops, which were sold under 27 different brands and formulations, following the FDA’s recommendation.

It’s worth noting that the FDA lacks the legal authority to compel drug manufacturers to recall their products; instead, it relies on companies to voluntarily initiate recalls. However, the FDA has recently sought greater authority from Congress to mandate such recalls.

Kilitch Healthcare has stated that it has not received any reports of adverse events related to its products, although these drops could potentially cause vision loss or blindness, according to the FDA. The products were distributed in the U.S. by Velocity Pharma and carry expiration dates ranging from November 2023 to September 2025.

This incident highlights the challenges the FDA faces in ensuring the safety of foreign products imported to the U.S., particularly in the context of pharmaceutical supply chains originating in countries like India. Despite efforts to increase inspections, the agency struggled to maintain oversight during the COVID-19 pandemic.

CVS Health has already ceased the sale of the affected eye drops, both in stores and online, offering customers a full refund. However, there has been no response from Target or Cardinal Health regarding the issue.

In a related development earlier this year, a separate outbreak of drug-resistant bacteria was linked to eye drops from different companies, leading to severe health consequences for some individuals. These incidents underscore the importance of rigorous quality control and oversight in the pharmaceutical industry.

Frequently Asked Questions (FAQs) about Recalled Eye Drops

More about Recalled Eye Drops

• FDA Preliminary Inspection Report
• Recall Notice by Kilitch Healthcare
• CVS Health Statement
• FDA’s Role in Product Recalls
• CDC Report on Eyedrop-Related Bacterial Infections