The FDA, disappointed in the manufacturing methods it saw at a Chinese API maker’s facility during a fall inspection, first put Sichuan Friendly Pharmaceutical on its import alert list and has now nailed it with a warning letter.
The letter was posted Tuesday for the Sichuan Friendly Pharmaceutical plant at Neijiang, Sichuan, following an inspection in October. One issue pointed out by inspectors is that the plant had no data to support the shelf life labeled on the company's APIs.
The FDA also said the Sichuan Friendly facility did not test for residual solvent levels in its intermediate or finished API batches to determine whether results fell within acceptable levels. It also found the company manufacturing APIs that use different solvents on the same equipment. That included a class 2 solvent.
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The FDA pointed out that class 2 solvents, because of their inherent toxicity, must be limited and controlled to protect patients from potential adverse effects. The FDA ordered the company to produce a comprehensive risk assessment of all products distributed within the United States that did not undergo residual solvent testing.
The agency put the company on its import alert list in March.
The FDA has been busy with inspections in China of late. It recently posted a warning letter for Chinese API maker Yinghua Biochemical and Pharmaceutical Co., citing its facility in Yunnan, China, after noting repeat manufacturing issues.