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FDA Warns Chinese OTC Drugmaker

Posted 08 April 2019 | By Zachary Brennan 

FDA Warns Chinese OTC Drugmaker

The US Food and Drug Administration (FDA) last month sent a warning letter to Linyi, China-based Dong Yuan Technology Co., following a five-day inspection in September 2018 that uncovered significant violations of current good manufacturing practice regulations for finished pharmaceuticals.

Specifically, FDA cited the firm for having inadequate lab controls and failing to follow its lab procedures. FDA said the company’s lab assay methods for its over-the-counter (OTC) drug product, which is a spray, “have not been shown to be equivalent to or better than United States Pharmacopeia (USP) 41 compendial methods.”
In addition to finding the firm’s process validation program is inadequate, Dong Yuan also failed to ensure that its lab data was complete.

“Due to your failure to retain laboratory data, our investigator was unable to confirm the validity of your results. You could not provide any rationale for failing to maintain the complete data. Your staff further stated to our investigator that if a sample preparation is not good, it is thrown away and restarted. The staff does not retain that data,” the warning letter says.

Warning Letters Piling Up

The letter is the latest in a series of warning letters issued to China-based OTC drugmakers.

Earlier this year, FDA warned Hangzhou Sunking Nonwovens Co., which was placed on import alert last December, and highlighted how its OTC drug products were released for distribution in the US without appropriate quality control release testing.

Hangzhou Guoguang Touring Commodity Co. was found to have violated GMP requirements by manufacturing drugs on shared equipment without validated cleaning procedures, having an inadequate quality control unit and failing to adhere to product testing requirements.

In March 2018, FDA also cited OTC drugmaker Zhejiang Ludao Technology Co., after FDA found computer files in the recycle bin for the company's stand-alone high-performance liquid chromatography system.

An FDA inspection of Shanwei Honghui Daily Appliance’s facility in July and August 2018 uncovered “filling machines used to manufacture over the counter (OTC) drug products for the U.S. market” that “were filthy and were surrounded by cardboard and dirty rags.” 

And following a March 2018 inspection, China-based Hangzhou Karic Commodities was also cited over the release of several OTC drugs that had not been subject to adequate testing for the identity and strength of active ingredients.

Dong Yuan Technology Co., Ltd. 3/18/19

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