Topic: FDA warning letter

China

FDA savages Chinese API maker in warning letter

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.
pills

Interpharm gets FDA warning letter for Czech plant

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.