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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze