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The USA FDA has restricted the import of some products produced by Viatris' pharmaceutical plant in India.
On December 23, Glonghui reported that Viatris announced on Monday that the USA Food and Drug Administration (FDA) has imposed import restrictions on 11 products produced at its manufacturing facility in India, due to violations of federal requirements. The FDA issued a warning letter to the pharmaceutical company after inspecting the facility, stating that these products will no longer be accepted in the USA until the warning letter is lifted. Viatris indicated that the FDA made conditional exceptions for four products based on shortage issues. The company has immediately implemented a remediation plan on-site and stated that necessary corrective and preventive measures are proceeding smoothly. The company has also hired
Viatris Issues Statement Regarding Receipt Of Warning Letter And Import Alert For Indore, India Facility; The Import Alert Affects 11 Actively Distributed Products That Will No Longer Be Accepted Into The U.S. Until The Warning Letter Is Lifted
Express News | Viatris Inc: There Could Be Potential for Additional Exceptions by FDA Based on Further Discussions Related to Import Alert
Express News | Viatris: Engaged Independent Third-Party Subject Matter Experts to Support Remediation Plan
Express News | Viatris: Necessary Corrective and Preventive Actions Well Underway, Including but Not Limited to Related Personnel Actions