The FDA put a Chinese biologics drugmaker on import alert and followed up with a warning letter after an inspection a year ago that found serious microbial contamination at its plant in Hebei.
The FDA posted the warning letter today for Hebei Yuxing Bio-Engineering, after putting the company on its import alert list on July 8, and so banning its products from entering the U.S.
It said the company, which bills itself as the world’s largest maker of Vitamin B12, documented 67 microbiological contamination deviations between January 1 and August 20, 2015. But the agency said that microbiological contamination has been “a persistent and unresolved problem” at the facility since 2013.
The FDA said that while the company believes it identified four possible causes, including failing to carefully sterilize tanks used to store supplements. Hebei Yuxing Bio-Engineering has not gotten to the root cause and resolved the issue in three years.
But its problems go deeper, including using “experimental” analyses of samples that were then deleted from the audit trail provided to the FDA if that did not pass. Investigators found more than 2,400 of these tests in a folder on a piece of equipment. “Your management provided different explanations in an attempt to justify the practice, including ‘fear’ that the sample results would not pass,” the FDA said in its letter.
The FDA acknowledged the company was taking steps to fix some of the problems, including acquiring some new equipment for testing. The FDA was not satisfied, saying none of those actions will fix the problems until the company establishes procedures that “ensure that your quality unit reviews all production and control data and associated audit trails as part of the batch release process.”
In fact, the FDA laid out a long list of steps the drugmaker must take before it can regain FDA approval for the facility.
The FDA has significantly stepped up its oversight of manufacturing facilities in China, issuing warning letters in recent weeks to a growing number of companies there. Earlier this month, the FDA issued a warning letter for a facility of one of China’s largest manufacturers, Zhejiang Hisoar Pharmaceutical, in Taizhou City. It said the company routinely failed to do microbial testing on APIs shipped to the U.S. while repeatedly deleting test results when batches failed the tests did perform. Zhejiang Hisoar was put on the FDA import alert list in January.
- here’s the warning letter
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