FDA officials have released their preliminary inspection report on the India-based factory of Global Pharma Healthcare Ltd., the manufacturer of EzriCare and Delsam Pharma’s recalled eye ointment and drops that have been linked to deaths and injuries across the United States.
Give me some background.
The CDC announced in January 2023 that it was investigating an outbreak of cases of a drug-resistant bacteria in clusters within multiple states that were linked to various infection sites.
The outbreak was connected to the use of 10 different brands of over-the-counter (OTC) artificial tears, with EzriCare Artificial Tears being the most commonly-reported brand used by consumers. Also included in the list was Delsam Pharma’s artificial tears and, later, eye ointment.
While the CDC originally issued a voluntary recall for EzriCare, it was escalated to a Health Alert Network (HAN) Advisory in February 2023.
As of March 2023, 68 cases across 16 states have been reported, including 8 cases of vision loss, 4 reports of enucleation, and 3 deaths.
Now talk about this report.
FDA investigators inspected the Global Pharma facility—for the first time, according to the agency—February 20 through March 2, 2023.
A list of 11 observations were reported, including dirty equipment and clothing; a lack of established written procedures for equipment maintenance and cleaning; as well as the absence of other procedures and safeguards such as not performing required testing, validity, or identity verification on products.
Any other specifics?
In lieu of any rigorous procedures in place for ensuring fully-sealed bottles, the inspectors noted that “a manual visual inspection is the only test to detect any leak.”
Other observations included a “manufacturing process that lacked assurance of product sterility,” specifically for product batches that were manufactured between December 2020 and April 2020 and shipped to the United States for commercial distribution.
Read the full preliminary report here for further details..
What’s next?
A formal report will likely be released with additional information regarding the FDA inspectors’ observations as part of an ongoing compliance matter, as well as a warning letter to Global Pharma.