U.S. health inspectors discovered numerous sanitation and manufacturing issues, such as barefoot workers, cracked floors, and altered records, at an Indian company that recently issued a recall on its eyedrops sold in the United States.
The Food and Drug Administration (FDA) discovered multiple issues at a Mumbai facility owned by Kilitch Healthcare India. The agency posted a preliminary inspection report detailing over 12 problems. The factory manufactured 25 different types of eye drops, which were recently the subject of an FDA safety advisory.
CVS Health, Target, Rite Aid, and other major retailers have announced that they will no longer sell these products and have removed them from their shelves. The FDA’s recent inspection of the plant revealed additional issues with the production process.
Inspectors from the agency recorded instances of factory employees not adhering to safety protocols, such as wearing masks, gloves, and gowns, and working without shoes in areas that require sterility. According to the report, a manager informed FDA officials that this was their usual practice.
In other areas, employees of the FDA observed floors with cracks, along with water marks and chipping paint on the walls and ceilings.
According to the FDA report, factory personnel would frequently leave out or fabricate contamination test findings.
An example would be a factory microbiologist stating that any bacterial sample that surpasses the “alert or action limit” would not be documented. Instead, officials would conduct extra cleaning and document a number that showed sterility. The microbiologist reported that this happened “two or three times a month”.
The preliminary results from the FDA will likely be followed by an official report and a letter of caution to the company.
Kilitch Healthcare issued a recall for their lubricating eyedrops on Monday. The recalled product was sold under 27 different brands and formulations. The notice was posted on the agency’s website on Wednesday. This recall is essentially a formality as the FDA had already informed stores and consumers in the U.S. about the issue.
The FDA lacks the legal power to compel drug makers to withdraw their merchandise from the market, and instead depends on companies to do so willingly. On October 25, the FDA advised the recall, and soon after, prohibited imports from Kilitch.
According to a statement from an agency spokeswoman on Thursday, pharmaceutical manufacturers and distributors are accountable for the quality of their products. However, the FDA has requested the power to require recalls from Congress.
According to the FDA, Kilitch Healthcare has not received any reports of negative outcomes associated with their products. However, the drops may potentially lead to loss of vision or blindness.
Velocity Pharma, located in Farmingdale, New York, distributed the lubricating drops in the United States. These drops have expiration dates ranging from November 2023 to September 2025.
According to FDA records, Kilitch Healthcare has not been previously inspected.
The FDA is in charge of ensuring the safety of products from other countries that are sent to the U.S. However, it has faced challenges in keeping up with the growing number of pharmaceutical supply chains that originate in India.
The agency has been making efforts to compensate for skipped inspections that were not carried out during the COVID-19 pandemic. According to agency records, no inspections were conducted by the FDA in India in fiscal year 2021 due to the peak of the pandemic. The number of inspections increased to 177 in fiscal year 2023, but this was still only about half of the number conducted before COVID-19.
CVS Health stated that they have halted the sale of all the FDA-listed eyedrops in both their physical stores and online. Customers can receive a full refund by returning them to a CVS location.
Target and Cardinal Health did not answer questions sent via email regarding their products.
In the beginning of this year, government authorities connected a separate occurrence of drug-resistant bacteria to eye drops produced by two distinct companies, EzriCare and Delsam Pharma.
The latest report from the Centers for Disease Control and Prevention states that over 80 individuals in the United States have been diagnosed with eye infections caused by an uncommon bacterial strain. Of these cases, 14 resulted in loss of vision, four required removal of the affected eye, and four were fatal.
In February, following a recall of the products, health inspectors conducted a visit to the manufacturing facility in Tamil Nadu, India where the eyedrops were produced. During their inspection, they discovered issues with the production and testing process, specifically with regards to sterilization measures.
The Howard Hughes Medical Institute’s Science and Educational Media Group provides support to The Associated Press Health and Science Department. The AP is solely responsible for all of its content.