FDA Warning for Chinese Manufacturer

July 7, 2016
Pharmaceutical Executive

July 7, 2016

FDA issued a warning letter to Guangzhou Haishi Biological Technology Co., Ltd. on June 22, 2016, stating the company had violated current good manufacturing practice (CGMP) regulations at its Guangdong facility. The letter addresses the company’s response to violations found by FDA investigators during a July 2015 investigation.

The FDA investigation found that the company had not tested finished drug products for the identity and strength of the active ingredient and had “failed to conduct at least one specific identity test on a component when relying on that component supplier’s analysis.” The warning letter also states that the company did not have adequate written procedures for production and process control to assure the identity, strength, quality, and purity of their products. FDA wrote, “In your firm’s response of August 14, 2015, you state that you will purchase analytical instruments and standards to conduct incoming material testing and finished product testing.  However, your response is inadequate as you did not commit to testing every batch of finished product prior to release. Furthermore, you did not include a risk assessment for all your drug products within expiry that have been distributed to the United States.”

According to the warning letter, the FDA inspection resulted in the company being placed on Import Alert 66–40 on March 14, 2016 and that FDA may continue to refuse admission of products manufactured at the Guangdong facility if the company fails to correct the violations.

Source: FDA