Topic: FDA warning letter
A Spanish API maker was criticized in an FDA warning letter for poor cleaning procedures, as well as for issues with equipment that was repaired with materials the agency said might actually affect the quality of its APIs.
The FDA has issued a warning letter to a Chinese heparin maker for some of the same kinds of issues raised by the EU earlier this year.
In this week's FiercePharmaAsia wrap-up, China has become first to test CRISPR in human, GSK is being sued by private investigators, and more.
For the second time in recent weeks, the FDA has slapped a Japanese API maker with a warning letter, this time for data integrity problems at Sekisui Medical.
The FDA has savaged a Chinese API maker in a warning letter for a long list of violations, including hiding questionable products, lying to inspectors about products made at the Beijing plant and systemic data manipulation.
A Czech drugmaker that ships both APIs and finished products to the U.S. has come under fire from the FDA in a warning letter for data integrity issues that the agency says leave questions about the quality of the company’s drugs.
The FDA has posted the warning letter that Teva recently acknowledged getting for its troubled sterile manufacturing plant in Hungary, outlining concerns about sterility and contamination issues at the plant.
Eagle Pharmacy, an Alabama drug compounder, was slapped with a warning letter by the FDA for unsanitary conditions and failing to register new compounds.
The regulatory quagmire has deepened for the Teva Pharmaceutical sterile injectables plant in Hungary which the FDA banned this year over slipshod manufacturing standards. The FDA has now issued the plant a warning letter.
The FDA named two European drug manufacturers--Delarange Cosmetics & Healthcare of the Netherlands and Wallace Cameron of the U.K.--in separate warning letters, citing poor quality control, filthy equipment and failure to register with the agency.