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Home » Chinese Devicemaker Warned for Testing, Cleaning Validations
Chinese Devicemaker Warned for Testing, Cleaning Validations
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter to Foshan Biours Biosciences, a combination drug/device manufacturing facility in Guangdong, China, following a records-based inspection that revealed inadequate testing and cleaning validation for the company’s biomedical patch.