FDA hits Chinese OTC drugmaker with warning letter over data, testing issues

The FDA has issued a warning letter to Chinese OTC drugmaker Zhejiang Ludao Technology over data integrity and product testing issues.

The FDA issued a warning letter to Chinese OTC drugmaker Zhejiang Ludao Technology, citing data integrity and product testing issues.

In the warning letter, the regulatory agency said the company lacked basic laboratory controls to prevent changes to paper and electronic records. The FDA also noted that the company admitted during an inspection in August to falsifying certificates of analysis for four batches of OTC products before the products were manufactured.

Additionally, inspectors found computer files in the recycling bin for the company's standalone high-performance liquid chromatography system. In its warning, the FDA said the system did not have audit trail capabilities and the company was unable to explain why the files were deleted.


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Before the inspection last summer, the agency detained and tested samples from a batch of an OTC spray made by Zhejiang Ludao that had nearly twice the amount of active ingredient specified on the label. According to the FDA, the company has agreed to reformulate the spray and update its test methods to conform to the corresponding USP monograph.

Zhejiang Ludao was placed on an import alert in late December.

In November, the agency slapped a warning letter on another Chinese OTC drug manufacturer that shipped multiple lots of an OTC product to the U.S. containing the wrong API because the company messed up a translation. That warning went to Guangdong Zhanjiang Jimin Pharmaceutical and cited a number of issues, including the discovery that it was using the wrong API for an anti-itch product that was labeled as containing hydrocortisone.


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