Aspen Pharmacare has been rapped over the knuckles by the US Food and Drug Administration and issued with a warning letter for failing to take sufficient steps to prevent microbial contamination at a key facility in Gqeberha that makes eye drops and many other medicines requiring sterile production.
In the letter, the agency noted that Aspen – which sells its own drugs and develops and manufactures medicines for other companies – failed to establish scientifically sound laboratory controls to ensure products conform to appropriate standards for strength and quality.
Aspen’s Gqeberha site has three units that manufacture sterile products, only one of which makes eye drops. Aspen also makes sterile products at its Notre-Dame-de-Bondeville facility in France.
Its eye drops are marketed exclusively in the US and are manufactured under contract for a customer it declined to identify, reports BusinessLIVE. The export revenue generated by these products is not material to Aspen’s group turnover, said COO Lorraine Hill.
“FDA regulations pertaining to eye drop manufacturing have become more stringent, essentially increasing from an over-the-counter standard to a pharmaceutical injectable manufacturing standard,” she said.
The FDA sent a warning letter to Aspen on 24 February, which it published on its website on 18 March. It follows an FDA audit last September of the unit at the Gqeberha facility, which concluded Aspen had insufficient controls in place to ensure sterile products were not contaminated.
The FDA’s letter, which is partially redacted, says Aspen did not establish scientific systems to monitor impurities during stability testing of products containing the active pharmaceutical ingredients naphazoline hydrochloride or tetrahydrozoline hydrochloride. They are found in non-prescription eye drops used to treat redness caused by minor irritations.
It said FDA inspectors had found levels of impurities – which it did not identify – that might pose a risk to patient safety.
Hill said Aspen had suspended all eye drop manufacturing from September, and the company was working closely with the FDA to address its concerns. Aspen would resume export of the products to the US as soon as it had remediated the FDA’s findings, she said.
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