Another Chinese drugmaker has been written up by the FDA for manufacturing products with essentially no protections in place to assure they are safe and effective.
The most recent letter posted is for Concept Products, a Tianjin, China company that the FDA inspected over several days in August 2015. In the letter released this week, the FDA said the company did not test every batch of products shipped to see if they met specifications for the usual things like the identity and strength of the API.
It said the company did not write up or follow any processes for holding each lot for sampling. It never got the OK from the quality control people before release, and also didn't do stability testing to determine how the APIs should be stored and their appropriate expiration dates.The company also did not have established procedures for regularly cleaning and maintaining equipment.
When the company responded, it acknowledged the seriousness of the issues but didn’t commit to fixing them, the FDA said.
China has become the global leader in API production but not in oversight of its companies. The FDA has stepped up its own inspections there and that has resulted in a series of warnings for Chinese companies, large and small in recent months.
China’s Xiamen Origin Biotech was recently cited for essentially having no written procedures in place and falsifying certificates of analysis sent to customers. The Fujian-based company, which has been placed on the FDA’s import alert list, didn’t even respond to the action.
Among others, the FDA recently issued warning letters to plants operated by Shanghai Desano Chemical Pharmaceutical, which does work for GlaxoSmithKline’s ($GSK) ViiV Healthcare, and Chongqing Lummy Pharmaceutical, slamming them both for manipulating testing and turning in falsified batch test results on APIs.
- here’s the warning letter