By Joe Hoppe
Beximco Pharmaceuticals said that an inspection by the Malta Medicines Authority of its ophthalmic manufacturing unit found several deficiencies, including one critical issue and three major deficiencies.
The AIM-listed pharmaceutical company said Monday that the manufacturing facility had previously received Good Manufacturing Procedure certification from other European Union member states.
The inspection audit, carried out between July 28 and Aug. 1, found issues including a critical deficiency finding related to the unit’s building management system.
The company said it doesn’t currently export ophthalmic products from this manufacturing unit to the EU or to the European Economic Area, and while the MMA has proposed the EU prohibits the company from exporting these products in the EU or EEA, the proposal hasn’t yet been ratified by the EU.
Total sales of the products from the unit constituted less than 1% of group sales in the year ended June 2022.
“The company is working closely with the MMA to implement remedies to all observations cited in the report in a timely manner, including the installation of a new BMS system, ahead of another audit by the MMA expected in early 2024,” the company said.
The inspection finding isn’t relevant to Beximco’s other manufacturing units and the cost of the remedies won’t materially financially affect the company’s performance for the current financial year, the company said.
Write to Joe Hoppe at joseph.hoppe@wsj.com
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