RAPS: FDA Says Chinese API Manufacturer Falsified Drug Data

The US Food and Drug Administration (FDA) has sent a Warning Letter to a Chinese active pharmaceutical ingredient (API) manufacturer after finding that the firm did not exercise proper control over its manufacturing data. The Warning Letter, sent to Yunnan Province-based Yunnan Hande Bio-Tech, is the latest in a long string of warnings from FDA related to data integrity concerns. As detailed by Regulatory Focus, more than a dozen Indian drug manufacturers have been warned by FDA since 2013 for data integrity-related deficiencies. Several other Chinese manufacturers have also been warned in recent years.