WASHINGTON – An Indian company that recently recalled eyedrops sold in the U.S. had a host of sanitation and manufacturing problems, including barefoot workers, cracked floors and altered records, U.S. health inspectors found.
Food and Drug Administration officials uncovered more than a dozen problems at the Mumbai plant operated by Kilitch Healthcare India, according to a preliminary inspection report posted by the agency. The factory produced more than two dozen varieties of eyedrops that were subject to an FDA safety warning last month.
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The products were sold by CVS Health, Target, Rite Aid and other national retailers who said they would be removed from store shelves. New details about the plant's problems emerged after FDA inspectors visited the plant late last month.
Agency inspectors documented factory workers not wearing masks, gloves and gowns and working barefoot in areas that are supposed to be sterile. A manager told FDA officials “that this is their standard practice,” according to the report.
Elsewhere, FDA staff noted cracked floors, plus water stains and peeling paint on walls and ceilings.
The FDA report also suggests factory officials would routinely omit or falsify contamination test results.
For instance, a factory microbiologist said that a bacterial sample that could trigger “an alert or action limit” would not be documented. Instead, officials would perform additional cleaning and then record a figure that indicated sterility. This occurred “two or three times per month,” according to the microbiologist.
The FDA's initial findings are likely to be followed by a formal report and a warning letter to the company.
On Monday, Kilitch Healthcare officially recalled the lubricating eyedrops, sold in 27 different brands and formulations. The agency published the notice to its website Wednesday. The recall is something of a formality, since the FDA had already alerted U.S. stores and consumers to the problem.
FDA officials don't have the legal authority to force drug manufacturers to recall their products, and instead rely on companies to “voluntarily” do so. The FDA had recommended the recall on Oct. 25 and shortly thereafter blocked imports from Kilitch.
Drugmakers and distributors “are responsible for the quality of their products,” but the FDA recently asked Congress for the authority to mandate such recalls, an agency spokeswoman said in a statement Thursday.
Kilitch Healthcare said it has not received “any reports of adverse events” related to its products. The drops could cause vision loss or blindness, according to the FDA.
The lubricating drops were distributed in the U.S. by Velocity Pharma, based in Farmingdale, New York, and carry expiration dates between November 2023 and September 2025.
FDA records show no prior inspections for Kilitch Healthcare.
The FDA is responsible for assuring the safety of foreign products shipped to the U.S., though it has long struggled to keep pace with international pharmaceutical supply chains that increasingly begin in India.
Recently, the agency has been working to make up for missed inspections that weren't conducted during COVID-19. Agency records show FDA didn't conduct any inspections in India during fiscal year 2021, at the height of the pandemic. Inspections rose to 177 in fiscal 2023, but that was still about half the number of inspections that the FDA was conducting the year before COVID-19.
CVS Health said in a statement that it previously “stopped the sale in-store and online” of all the eyedrops cited by the FDA. Customers can return them to CVS for a full refund.
Target did not respond to emailed questions about the products. Cardinal Health, a medical supply company, also did not respond to emails.
Earlier this year, federal officials linked an unrelated outbreak of drug-resistant bacteria to eyedrops from two different companies, EzriCare and Delsam Pharma.
More than 80 people in the U.S. tested positive for eye infections from the rare bacterial strain, according to the most recent update from the Centers for Disease Control and Prevention. Among them, 14 people suffered vision loss, four had to have an eye removed and four died, the CDC said.
After the products were recalled in February, health inspectors visited the manufacturing plant in India’s southern Tamil Nadu state that made those eyedrops and uncovered problems with how they were made and tested, including inadequate sterility measures.
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