FDA inspectors conducted an inspection to Taizhou plant of Zhejiang Hisun Pharmaceutical Co., Ltd. in China during March 2-7, 2015 and significant deviations from current good manufacturing practice (CGMP) were founded. A Warning Letter was issued to the plant for serious data manipulation in December 2015.
1.Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.
2.Failure to conduct appropriate microbiological testing on API batches where microbial quality is specified.
In fact, before the Warning Letter, in September 2015, FDA issued an Import Alert to Hisun’s Taizhou plant to ban 15 drugs produced at the plant, but 14 other API product were excluded at the suggestion of the FDA's Center for Drug Evaluation and Research.
Hisun’s Taizhou plant is still under an Import Alert. However, on 18th February this year, FDA revised its ban against Hisun’s plant in Taizhou issued in September last year. According to the Import Alert, exclusion of Daunorubicin HCl was made because “Daunorubicin liposomal application (NDA# 50704) has critical drug shortage concern”.
It is reported that America had ever been in shortage of Daunorubicin liposomal injection in the past, but it was resolved in 2015.