FDA Warns Japanese, Chinese Drug Makers for Violations

Jan 19, 2017


The U.S. FDA sent warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

In its warning letter to Sato Yakuhin Kogyo, FDA cites the company for data integrity issues and failing to investigate out-of-specification test results uncovered over a five-day inspection of the company's Kashihara City, Japan, facility last June, according to Regulatory Affairs Professional Society.

According to FDA, the company performed duplicate high performance liquid chromatography sequences for some of its drugs, but only kept records of a second set of results, which the company used as the basis for release of the products, the story said.

Suzhou Pharmaceutical was placed on Import Alert from the FDA as a result of issues uncovered during a three-day inspection of the company's Suzhou, China facility last June.

FDA said, "Your firm has no Quality Unit. During the inspection, you provided no written documents describing the roles and responsibilities of a Quality Unit. You had no written procedures for quality activities."

Also, FDA says the company's salespeople were signing the certificates of analysis using the title "QC Director" and signing under "Tested by" indicating that tests had been performed when they had not been.

Read the full RAPS article