The manufacturer of the eye drops related to the deadly outbreak fails an inspection by the FDA.

At the facilities of Global Pharma, the FDA discovered brown slime and a lack of sterility tests.
According to an inspection report that was made public by the Food and Drug Administration (FDA), the manufacturer of the eye drops that have been linked to a deadly outbreak of extensively drug-resistant infections in the United States had a slew of manufacturing violations. These violations ranged from brown slime on filling equipment to a lack of basic measures and systems to ensure sterility (PDF).
Consumers were issued a warning in February to immediately discontinue the use of eye drops and eye ointment manufactured by Global Pharma. The company’s products were marketed in the United States under the brand names EzriCare and Delsam Pharma and were distributed by a variety of retailers including Amazon, Walmart, eBay, and others. In later years, recalls of the products were issued voluntarily by Global Pharma.
Investigators looking into matters pertaining to public health have established a connection between the drops and cases of a strain of Pseudomonas aeruginosa that was highly resistant to multiple antibiotics and was previously unknown in the United States. The strain is known as VIM-GES-CRPA, which is an abbreviation that stands for a carbapenem-resistant P. aeruginosa (CRPA) with Verona integron-mediated metallo—lactamase (VIM) and Guiana extended-spectrum—lactamase (GES). EzriCare was by far the most common brand of eye drop that afflicted individuals reported taking, despite their use of many other brands. In addition, the epidemic strain was found in opened bottles of EzriCare artificial tears, according to testing conducted by the Centers for Disease Control and Prevention as well as by researchers working independently.

According to reports from the Centers for Disease Control and Prevention (CDC), as of March 14 there have been 68 cases of infection with the strain across 16 states. As a result of the virus, three persons have passed away, eight others have suffered visual loss, and four more have had their eyeballs surgically removed.

The FDA found multiple production violations at Global Pharma back in February, but the inspection report details the full scope of the company’s failings. An inspection of Global Pharma’s production facility in Thiruporur, India (located just south of Chennai in the state of Tamil Nadu), which took place between February 20 and March 3 and resulted in a 14-page report, was conducted between February 20 and March 3.

The report of the inspection details eleven “observations” of problems, along with specifics about each one. The first problem is that Global Pharma doesn’t appear to have bothered to check whether or not the eye drops it sells are in fact sterile, despite the fact that it has stated that they are. According to the FDA inspection report, the filtering technology used by the manufacturer cannot “reliably sterilise” the eye drops since there is “not appropriate validation evidence to establish” that it can do so.
Fatal inadequacies
It appeared as though the facility was set up to manufacture things that were tainted. Inspectors from the FDA stated that Global Pharma did not check to ensure that the components of the solutions, which were purchased from suppliers, were sterile from the beginning. In addition, the portions of the facility that were supposed to be used for making the solution in an aseptic, or contamination-free, manner were not suitable for the production of sterile goods. That is to say, the surfaces of the walls, ceilings, and floors were not smooth and firm, as they should have been so that they could be easily disinfected. On the contrary, there were holes, fissures, and nails that were sticking out of the wall. According to the investigation, however, even if it were possible to clean the area, the company’s procedures for doing so were not up to par.

Inspectors from the FDA found issues with the cleanliness and upkeep of the machinery, which might have resulted in cross-contamination from other items made at the plant. On the second day of the inspection, an inspector saw a “black, brown coloured greasy layer” on portions of the filling machine. The equipment logbook for the facility stated that it hadn’t been cleaned in about a month, which was mentioned in the inspector’s observation. A management explained to the inspector a few days later that there was “no method for cleaning” the filling machine.
According to the findings of the investigation, environmental monitoring in the facility to look for signs of contamination was nonexistent. In addition, the sterility of the primary packaging, which included the tops of the bottles, was not checked before it was used. After the eye drops had been bottled, the formulation did not include a preservative to protect against the growth of microorganisms, and batches were shipped to the United States without first passing through the quality control unit.

Earlier, a CDC official expressed her concern to Ars about the epidemic of VIM-GES-CRPA in the United States, saying that she believed it might seed more infections and medication resistance. According to Marissa Grossman, who works for the CDC’s epidemic intelligence branch, “to far, widely drug-resistant Pseudomonas with genes that rapidly propagate resistance, like VIM and GES, have been uncommon in this nation.” She said that the extensive introduction of the epidemic strain poses a threat to efforts to prevent highly resistant organisms from becoming more common. “The widespread introduction of the outbreak strain…”

The Food and Drug Administration (FDA) issued recall letters for two additional brands of eye drops in the month of March, namely those manufactured by Pharmedica and Apotex. The epidemic of VIM-GES-CRPA has not been linked to any of the products, which both state on their labels that they were made in North America.

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