On Monday, Viatris stated that the US Food and Drug Administration (FDA) has imposed import restrictions on 11 products produced at its India-based pharmaceutical plant due to violations of federal requirements. After inspecting the facility, the FDA issued a warning letter to the manufacturer, stating that these products would no longer be accepted in the USA until the warning letter was lifted. Viatris indicated that the FDA made conditional exceptions for four products based on shortage issues. The company immediately implemented a remediation plan on-site and stated that necessary corrective and preventive measures are progressing smoothly. The company has also hired independent third-party experts to support the remediation plan.
美国FDA限制进口Viatris印度制药厂生产的部分产品
The USA FDA has restricted the import of some products produced by Viatris' pharmaceutical plant in India.
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