The FDA cited Anchen Pharmaceuticals for four violations at its manufacturing facility in Irvine, California, including particulate contamination. Source: Devices & Diagnostics Letter

The FDA issued a warning letter to DermaPharm for serious GMP violations including inadequate testing of raw materials and finished products. Source: Devices & Diagnostics Letter

The FDA has removed an Indian supplier of hydroxychloroquine and chloroquine APIs from an import alert to free up imports of the potential COVID-19 treatments from two of its plants.…

The FDA has granted Gilead’s remdesivir orphan drug designation as a potential treatment for COVID-19. Source: Devices & Diagnostics Letter

The agency said it wants to ensure that all incidents are fully investigated before any corrective actions are taken. Source: Devices & Diagnostics Letter

For other submission types, “we encourage you to submit the response or report when possible,” CDRH said. Source: Devices & Diagnostics Letter

Some devices may not slide out of their carrier tube because of a deformation in the rim. Source: Devices & Diagnostics Letter

NSAI said it will begin accepting applications for conformity assessment activities from April 1, 2020. Source: Devices & Diagnostics Letter

The device is used in AV fistula placement and phlebotomy procedures and has not yet received FDA clearance. Source: Devices & Diagnostics Letter

The CDC also reported increased demand for respirators and facemasks. Source: Devices & Diagnostics Letter