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. It listed about a dozen steps it wants the company to take to improve its systems, suggesting it bring in an expert to help get its operations in order.
The US FDA wants more information on Czech API firm Interpharm Praha AS’s efforts to prevent repetition of data manipulation uncovered during 2015 inspection.
Interpharm's Recieves USFDA Warning Letter