US FDA says Xiamen Origin Biotech lied to inspectors who visited API plant
The US regulator made the accusation in a letter posted on its site this week, suggesting the Chinese active pharmaceutical ingredient (API) manufacturer made misleading statements about activities at the site during a three-day visit that began on January 18.
According to Food and Drug Administration (FDA) one Xiamen employee told an inspector who observed relabelled pharmaceuticals that no drugs were stored at the site.
The same employee also claimed Xiamen had stopped relabelling drugs last January, despite export records indicating that it continued to distribute such products through to January this year.
The inspection team also uncovered and dirty warehouse spaces and a lack of written procedures for supplier qualification, sampling and product release. They also accused Xiamen of giving customers falsified certificates of analysis (CoA).
According to the FDA Xiamen has not responded to any of the observations or put together a remediation plan, although the firm did acknowledge its inclusion on the agency’s import alert in May.
The US regulator gave Xiamen another 15 days to respond and suggested it hire an expert to help it bring the facility up to code
