Chinese Drugmaker Earns Warning Letter Over Procedural Failures

A Chinese drugmaker is drawing heat from the FDA over three significant GMP violations uncovered at one of its facilities.

An inspection of Guangzhou Haishi Biological Technology’s manufacturing plant in Guangdong showed that the company’s quality unit did not test all product batches for identity and the strength of their active ingredients before distribution, according to an FDA warning letter.

In that same vein, investigators also found that the company lacked proper procedures for ensuring drug quality, purity and potency.

Lastly, the letter chides the company for failing to perform “at least one” identity test on a drug component, relying instead on the supplier’s analysis for confirmation.