The plant in Kunming, Yunnan Province was inspected in April last year by the US Food and Drug Administration (FDA) and a warning letter identifying deviations from current good manufacturing practice (CGMP) was sent to the company earlier this month.
“You lacked controls to prevent the unauthorized manipulation of your laboratory's electronic raw data. Specifically, your infrared (IR) spectrometer did not have access controls to prevent deletion or alteration of raw data,” the agency said.
During the inspection the FDA noted a Hande Bio-Tech employee failed to perform the IR identity test for lots of a specific API as part of the quality control release.
“Instead, the analyst at your firm altered the file name in the spectrophotometer containing the sample identification information… tested on April 2, 2014, to support the release of two previously manufactured lots.”
The inspectors also noted the firm’s quality unit’s failure to exercise its responsibility to ensure the APIs are in compliance with CGMP, and meet established specifications for quality and purity.
The letter is the second the facility has received in recent years, with the FDA hitting the firm with a warning in 2010 after complaints surrounding certain API batches were not investigated properly.
Yunnan Hande Bio-Tech manufactures the ingredients for the drugs paclitaxel and cephalomannine, both of which are major taxanes produced by yew trees and used to treat a number of types of cancer including ovarian, breast, lung and pancreatic cancer.
The company did not respond to requests for more information when contacted by this publication.