Topic: FDA warning letter


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.

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.