Chinese API maker Yinghua Biochemical and Pharmaceutical Co. was issued a warning letter by the FDA for data integrity issues and problems with its quality unit.
The agency said in a letter posted to its website that an inspection last October of its facility located in Nankou Industrial Park, Lijiang, Yunnan, China, uncovered repeat manufacturing issues that resulted from an inspection in 2015.
“Our current inspection identified multiple failures to implement your specific corrective actions,” the agency said. “These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drug products is inadequate.”
In the most recent inspection, the company was warned about data integrity questions and for allowing its quality unit to approve the certificate of analysis (COA) to release an API batch to a customer before testing was complete and available for review.
As a result of the inspection, the company was placed on the FDA’s import alert list in February.
The firm was also cited for lacking security controls to access its computer systems, specifically its high-performance chromatography (HPLC) and gas chromatography systems. Each of those systems had only a single username with administrator rights. That could allow any user to delete or modify files without being traced.