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FDA Details Manufacturing Conditions That Led to Eye Drop Recall
In an inspection lasting from February 20 to March 2, the FDA discovered sanitary issues and dangerous pharmaceutical manufacturing processes at the Global Pharma eye drop plant.
After a series of infections that left several blind, an FDA inspector discovered that the manufacturing facility used to create Global Pharma’s artificial tears failed to follow evidence-based procedures for sterilizing their products and that the facility itself was not in an appropriate condition to manufacture pharmaceuticals.
In late February, Global Pharma Healthcare voluntarily recalled batches of artificial tears linked to bacterial infections of Pseudomonas aeruginosa, VIM-GES-CRPA, a drug-resistant bacteria. The CDC initially connected the outbreak to at least 55 infections, which resulted in five cases of vision loss and one death.
During the February FDA inspection, officials from the administration found that Global’s eye products were filtered using a method not shown to sterilize the product. Additionally, no tests were conducted to ensure that the filtration process removed biological contaminants.
Regulators listed a minimum of 19 occurrences where either mandatory quality control tests were omitted, or there were indications of irregular testing.
In another observation, the inspector stated that workers in the clean room environment were wearing dirty equipment and that some of the machines used to manufacture or fill containers were contaminated or unclean.
“Written procedures are not established for the cleaning and maintenance of equipment. Established specifications, standards, sampling plans, test procedures, laboratory control mechanisms, are not followed or documented at the time of performance,” wrote the FDA inspector. “Drug product production and control records are not reviewed and approved by the quality control unit to determine compliance with all established approved written procedures before a batch is released or distributed.”
Altogether, the ten observations produced in the FDA report paint a picture of an almost totally uncontrolled environment without procedures for assuring the safety and sterility of the product being sold.
Since the initial infections and ensuing recall, the FDA has put Global Pharma on an import alert, and its US distributors have halted any sale of the tainted eye drops and ointment.
Following the voluntary recall from Global, Apotex and Pharmedica also issued recalls for some of their eye drop products. Both manufacturers were worried about the sterility of their drops, but neither had received complaints about incidents involving their products.
