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FDA Bans Pharmaceutical Ingredient Imports from Mainland Chinese Supplier

The U.S. Food and Drug Administration announced on 28 September that it will no longer allow imports of active pharmaceutical ingredients made by mainland China’s Zhejiang Huahai Pharmaceutical, located in Linhai in Zhejiang province. Huahai has been added to Import Alert 66-40 – detention without physical examination of drugs from firms which have not meet drug good manufacturing practices – following recent discoveries of problems regarding impurities in the company’s manufacturing process.

Huahai told customers in late June that it had found N-nitrosodimethylamine (NDMA), a probable human carcinogen, in its valsartan, an API used in blood pressure and heart failure medications. The company stopped exporting valsartan at that time but the FDA is now blocking all imports from Huahai after it found additional major manufacturing process issues during its plant inspection. As a result, no imports will be allowed until Huahai’s quality control systems meet FDA standards.

A report issued by the FDA on 3 August listed 11 problems requiring correction. The agency indicated that Huahai’s “change control system to evaluate all changes that may affect the production and control of intermediates or Active Pharmaceutical Ingredients (APIs) is not adequate.” A second carcinogenic impurity, N-nitrosodiethylamine (NDEA), was also detected in valsartan. Additionally, inspections conducted by the European Medicines Agency unearthed Huahai’s lack of compliance with good manufacturing practices.

Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of those laws and regulations to be detained without physical examination at the time of entry (e.g., a product contains illegal colours or food additives or a foreign firm refused an FDA inspection). Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers or shippers.

Firms and/or products on the “red list” of an import alert (such as Huahai) are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the United States if the importer has demonstrated that the shipment is in compliance.

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