FDA warns Lijiang Yinghua over repeated manufacturing failures

2 May 2018

The US Food and Drug Administration has sent an official warning letter to Yinghua Liu, the president of China-based API maker Lijiang Yinghua, related to problems concerning data integrity and quality.

In the letter, the agency states that problems uncovered during a 2015 visit to the firm’s Yunnan-based manufacturing facility had not been resolved at the time of an inspection last October.

The firm manufactures numerous key ingredients used in pharmaceutical products, including testosterone, progesterone and pregnenolone.

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