FDA Rebukes Chinese API maker Sichuan Friendly Pharmaceutical in Warning Letter

July 9, 2018  Source: FiercePharma 236

The FDA sent a warning letter to Sichuan Friendly Pharmaceutical after listing it in the import alert list due to its abysmal performance during a fall inspection. The FDA was not pleased with the manufacturing methods it saw at the Chinese API maker’s facility.

The letter was posted on Tuesday for the Sichuan Friendly Pharmaceutical plant at Neijiang, Sichuan, following an inspection in October. The agency put the company on its import alert list in March.

The inspectors noted a major issue which indicated that the plant had no data to support the shelf life labeled on the company's APIs. They reported that the Sichuan Friendly facility did not have any protocols to test for residual solvent levels in its intermediate or finished API batches to determine whether results were within normal levels. The FDA also found that the company was manufacturing APIs that use different solvents on the same equipment which also included a class 2 solvent.

Class 2 solvents, because of their inherent toxicity, must be limited and controlled to protect patients from potential adverse effects, says the FDA. It has asked the company to produce a comprehensive risk assessment of all products distributed within the United States that did not undergo residual solvent testing.

Currently, the FDA is keeping an eye on pharmaceutical companies based in China. It has been busy in conducting inspections at a number of manufacturing units. It recently posted a warning letter for Chinese API maker Yinghua Biochemical and Pharmaceutical Co., citing its facility in Yunnan, China, after noting repeated manufacturing defects.

By Ddu
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