A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago.
In the June 22 letter from the FDA, China-based Shandong Analysis and Test Center was warned that their drugs are considered adulterated under U.S. federal law, as the lab is not in compliance with current good manufacturing practices for API testing. The lab analyzes samples of heparin and heparin-related drugs for the presence of over-sulfated chondroitin sulfate (OSCS).
OSCS was at the root of the Chinese heparin scandal in 2007 and 2008, when Chinese manufacturers were found to be adulterating the anti-coagulation injectable heparin to cut costs. The contamination crisis killed at least 81 people and infected hundreds. Congress is still investigating what the FDA could have done better to halt the outbreak and enforce its regulations.
During a January 2017 inspection, Shandong Analysis and Test Center was found to have failed to ensure its API testing procedures are scientifically sound and valid. When a system suitability test failed, the lab did not investigate the failure.
In what the FDA called an inadequate response, the lab said it performed system suitability checks infrequently and promised to do so before analyzing batch samples in the future. The agency said Shandong Analysis and Test Center should be investigating “the validity of all test results for OSCS in heparin or heparin-related drugs during the period in which [it] failed to conduct system suitability in coordination with sample analyses.”
“It is critical that your system be demonstrated as suitable for detecting OSCS contamination in heparin to avoid the possibility of samples erroneously passing when an instrument is not working properly,” the FDA wrote.
The lab also was found to have failed to prevent unauthorized access or changes to data, it failed to provide adequate controls to prevent manipulation or deleting of data and refused or was unable to provide FDA investigators with testing data.
“During our inspection, we requested that you display original electronic data for analysis of heparin and heparin-related drug samples,” the letter said. “Your analyst was unable to retrieve the requested data and explained that he deletes older data to make space for newly acquired data.”