WASHINGTON — An Indian company that recently recalled eye drops sold in the US had a host of sanitation and manufacturing problems, including barefoot workers, cracked floors and falsified records, US 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 released by the agency. The plant produced more than two dozen types of eye drops that were the subject of an FDA safety warning last month.
The products were sold by CVS Health, Target, Rite Aid and other national retailers, which said they would remove them from store shelves. New details of the plant’s problems emerged after FDA inspectors visited the facility 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. One manager told FDA officials “that this was their standard practice,” according to the report.
Elsewhere, FDA staff found cracked floors and water stains and peeling paint on walls and ceilings.
The FDA report also suggests that factory officials routinely omitted or falsified contamination test results.
For example, a plant microbiologist said that a bacterial sample that could trigger an “alarm or action threshold” would not be documented. Instead, officials would carry out additional cleaning and then record a reading indicating sterility. This happened “two or three times a month”, the microbiologist said.
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 eye drops, which are sold in 27 different brands and formulations. The agency posted the notice on its website on Wednesday. The recall is a formality, as the FDA had already alerted US stores and consumers to the problem.
FDA officials don’t have the legal authority to force drugmakers to recall their products, relying instead on companies to do so “voluntarily”. The FDA recommended the recall on 25 October and blocked imports from Kilitch shortly afterwards.
Drugmakers and distributors “are responsible for the quality of their products,” but the FDA recently asked Congress for authority to order such recalls, an agency spokeswoman said in a statement Thursday.
Kilitch Healthcare said it had received “no reports of adverse events” linked to its products. The drops could cause vision loss or blindness, according to the FDA.
The lubricating drops were distributed in the US by Farmingdale, New York-based Velocity Pharma and have expiration dates between November 2023 and September 2025.
FDA records show no previous inspections for Kilitch Healthcare.
The FDA is responsible for ensuring the safety of foreign products shipped to the US, but it has long struggled to keep up with international pharmaceutical supply chains, which increasingly start in India.
Recently, the agency has been working to make up for missed inspections that weren’t conducted during COVID-19. Agency records show that in fiscal year 2021, at the height of the pandemic, the FDA didn’t conduct any inspections in India. Inspections rose to 177 in fiscal year 2023, but that was still about half the number of inspections the FDA conducted in the year before COVID-19.
CVS Health said in a statement that it had previously “stopped selling in-store and online” all of the eye drops 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 eye drops made by two different companies, EzriCare and Delsam Pharma.
More than 80 people in the US have tested positive for eye infections caused by the rare strain of bacteria, according to the latest update from the Centers for Disease Control and Prevention. Among them, 14 people suffered vision loss, four had an eye removed and four died, the CDC said.
After the products were recalled in February, health inspectors visited the plant in the southern Indian state of Tamil Nadu that made the eyedrops and found problems with how they were made and tested, including inadequate sterility measures.
