FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Chinese API Manufacturer Draws FDA Warning

July 6, 2018

The FDA placed Sichuan-based drugmaker Sichuan Friendly on an import alert after an October inspection of its facility in Neijiang City revealed stability and manufacturing issues with active pharmaceutical ingredients shipped to the U.S.

The agency found that the firm did not properly conduct residual solvent testing of its APIs distributed to the U.S. and it failed to test for residual solvent levels in intermediate or finished API batches to determine whether the results were within acceptable levels.

The firm also manufactured certain APIs on shared equipment, creating a risk of potential adverse effects due to the firm’s use of a class 2 solvent with an inherent toxicity that must be controlled to protect products.

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