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Regulatory Focus™ > News Articles > FDA Warns One Japanese, One Chinese Drugmaker

FDA Warns One Japanese, One Chinese Drugmaker

Posted 18 January 2017 | By Michael Mezher 

FDA Warns One Japanese, One Chinese Drugmaker

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Sato Yakuhin Kogyo

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 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.

"Your analysts told our investigator that, until June 1, 2016, they were permitted to perform repeat testing without scientific justification or documentation. They also told our investigator that they were not required to maintain the data from the original results when performing investigations of system suitability failures, suspected errors, or out-of-trend results," FDA writes.

Additionally, FDA says the company failed to maintain electronic records from its ultraviolet-visible spectrophotometer (UV SP-502) used for uniformity and identity testing.

While FDA says that Sato Yakuhin acknowledged that its data integrity controls for the UV SP-502 were deficient and that it plans to upgrade its systems, the agency says its response is inadequate.

"You have not conducted a retrospective review to determine how your failure to maintain complete records affected the quality of your drugs. Moreover, you have not shown how your revised laboratory procedures prevent the deletion, manipulation, or exclusion of data from the records relied upon for batch release and other quality review decisions," FDA writes.

As a result of these deviations, FDA is requesting Sato Yakuhin Kogyo undergo a comprehensive review of its quality system to ensure data integrity going forward. On top of the quality system review, FDA has also asked the company to provide a series of reports covering some of the company's microbiological testing methods and manufacturing processes.

Suzhou Pharmaceutical

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

Now, in a warning letter sent to the company earlier this month, FDA details the host of violations it uncovered.

According to the agency, the company completely lacks a quality unit.

"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," FDA writes.

Furthermore, 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.

FDA also said the company did not have a temperature and humidity control system at the site, and left windows open to try to lower temperatures.

Additionally, FDA says the Suzhou Pharmaceuticals shipped products to the US with active pharmaceutical ingredients made by another manufacturer, while that manufacturer was on import alert, and in its import declaration, Suzhou claimed that itself as the manufacturer.

Warning Letter - Sato Yakuhin Kogyo Co., Ltd.

Warning Letter - Suzhou Pharmaceutical Technology Co., Ltd

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