The US Food and Drug Administration have made it clear time and again that it wants to deploy more inspectors in China. The federal agency recently issued yet another warning letter, this time to an active pharmaceutical ingredients’ supplier operating from Wuxi, an industrial town in China. The letter stated that the supplier had violated fundamental manufacturing regulations on several fronts.
In October last, during an inspection, inspectors from the US FDA observed that the Novacyl Wuxi Pharmaceutical facility’s employees did not maintain the stipulated log of raw data verifying that their products met mandates. The FDA then went on to issue a warning letter to the firm in December 2014, describing that maintaining such records was a ‘basic responsibility’, and justifying their concerns in detail in the letter.
A blog in the Wall Street Journal, which touched upon this topic stated that they had approached the Chinese firm’s France-based parent company Novacap, and were awaiting a comment. According to this blog, the FDA’s warning letter does not specify the exact ingredients produced at the Chinese facility. However, a look at the website of Novacyl shows that this ingredient could possibly be acetaminophen.
The FDA noted that other reasons that promoted it to shoot a warning letter to Novacyl in China were: failure to appropriately investigate/document discrepancies, set up and implement appropriate lab controls or document GMPs.
Of late, the increasing reliance of pharmaceutical companies on China as a manufacturing base has been a concern. Many of these companies manufacture products that form a part of the product supply chain in the United States. In 2008, for instance, the FDA established an office in China after the blood thinner heparin had to be recalled after reports confirming that a fake active ingredient was used in it. Matters were made worse because 246 reportedly died in the U.S. owing to this product.