The US Food and Drug Administration (FDA) has raised serious concerns regarding the manufacturing standards of eye drops produced by Aspen Pharmacare at its sterile facility in Gqeberha, South Africa. In a warning letter, the FDA highlighted potential risks of microbial contamination due to inadequate controls.
The FDA’s warning letter, published following a September audit, revealed that Aspen’s manufacturing processes did not adequately prevent product contamination. The Gqeberha facility, which includes three sterile product units, manufactures eye drops exclusively for the US market under contract for an undisclosed customer.
Insufficient quality controls
The FDA’s audit concluded that Aspen lacked sufficient controls to ensure the sterility of its products. The partially redacted letter specifically noted the absence of scientific systems to monitor impurities during stability testing of eye drops containing naphazoline hydrochloride or tetrahydrozoline hydrochloride, active ingredients used to treat eye redness.
FDA inspectors detected unspecified impurity levels that could risk patient safety. The agency’s stringent regulations for eye drop manufacturing, now aligned with pharmaceutical injectable standards, underscore the criticality of maintaining high-quality controls.
Aspen’s remediation efforts
Aspen Pharmacare’s Chief Operating Officer, Lorraine Hill, confirmed that the company suspended all eye drop manufacturing at the Gqeberha facility in September following the FDA audit. The company is actively collaborating with the FDA to address the identified issues.
Aspen intends to resume exporting eye drops to the US market once it has successfully remediated the FDA’s findings. The company acknowledges the increased stringency of FDA regulations for eye drop manufacturing.
Hill said that the export revenue generated from these eye drops is not material to Aspen’s overall group turnover. The Americas region, which includes the US market, contributed R6.7 billion (15%) to Aspen’s total group revenue of R44.7 billion in the fiscal year ending June 30, 2024.
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