Global Pharma Healthcare — whose eye drops have been linked to a deadly outbreak of bacterial infections — did not follow proper sterilization or cleaning procedures at its manufacturing facility, according to a report from the U.S. Food and Drug Administration (FDA).
Last month, federal inspectors wrapped up their inspection of Global Pharma Healthcare's facility in India where the company manufactured EzriCare and Delsam Phama Artificial Tears products.
Both products were recalled in February due to potential microbial contamination amid a multi-state outbreak of drug-resistant bacteria that's now being investigated by state and federal health officials.
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As of March 14, nearly 70 patients in 16 states have been infected with a "rare strain" of Pseudomonas aeruginosa, 37 of which were linked to four health care facility clusters, according to the Centers for Disease Control and Prevention (CDC).
In total, three people have died from infections. Eight patients have suffered vision loss and four others have had to have their eyeballs removed, according to the CDC. A Florida woman who had her eye removed in September 2022 filed a lawsuit against the Global Pharma claiming the product made her legally blind.
In the FDA's inspection report, published Friday, investigators said the company "used a manufacturing process that lacked assurance of product sterility."
Federal officials also said the company "lacked a clear and specific written procedure for aseptic interventions performed." Aseptic is when something is free of contamination.
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The company also "did not track or have studies to show how many times" clothing could be re-used by workers, the FDA said. Investigators also noticed that the booties workers used at the facility were "discolored" and "worn-out."
Among the issues, officials also discovered discrepancies in the company's records as well as improper cleaning procedures and equipment.
For instance, certain surfaces "were not cleaned, sanitized, decontaminated, or sterilized, and there were no written procedures indicating any such activities should be performed," officials said.
Additionally, "the equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use," the report continued.
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Most patients that have been infected have reported using the EzriCare Artificial Tears, which is a preservative-free, over-the-counter product, according to the CDC investigation. Laboratory testing by the CDC identified the presence of bacteria that matches the outbreak strain in opened EzriCare bottles from multiple lots.
The FDA also announced that 50,000 tubes of Delsam Pharma’s Artificial Eye Ointment, which was also manufactured by Global Pharma and initially recalled in February, was contaminated with bacteria.
Patients that have used either recalled product and who are showing signs or symptoms of an eye infection should get medical help "immediately," health officials said.
