US FDA warns API firm Hebei Yuxing Bio-Engineering

By Gareth Macdonald contact

- Last updated on GMT

Hebei Yuxing Bio-Engineering in Hebei, China
Hebei Yuxing Bio-Engineering in Hebei, China

Related tags: Bacteria

Banned API firm Hebei Yuxing Bio-Engineering has had a microbial contamination problem at its plant since 2013 according to the US FDA.

The US Food and Drug Administration (FDA) criticized operations at the facility in Hebei, China in a warning letter​ published this week, citing an inspection conducted in August 2015 as evidence of a “persistent and unresolved problem​.”

At the time of the inspection, your firm had documented 67 deviations regarding microbiological contamination…These deviations occurred between January 1 and August 20, 2015, but our investigation documented that microbiological contamination has been a persistent and unresolved problem at your firm since 2013​.”

In its response to the 2015 inspection, Hebei suggested the microbial contamination was due to a number of factors including operator error and inadequate sterilization of storage tanks.

The FDA acknowledged this but stressed that Hebei has “not definitively identified the specific root causes of your microbiological contamination problems” or “taken appropriate corrective actions and preventive actions​.”

Other problems

In the letter the FDA also accuses Hebei of not recording “experimental” tests on APIs conducted in its quality lab, deleting chromatography data and failing to investigate deviations

The warning follows up on the import alert imposed on the firm earlier this year​. 

Hebei Yuxing did not respond to a request for comment.

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