Regulatory Focus™ > News Articles > FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues

FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues

Posted 24 August 2017 | By Michael Mezher 

FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues

The US Food and Drug Administration (FDA) has warned Chinese over-the-counter (OTC) drug and cosmetics maker Bicooya Cosmetics Limited over poor sanitary conditions and data integrity issues at its Zhejiang, China facility.

The warning letter comes after a four-day inspection of the facility last May that resulted in FDA placing the firm on import alert in late June.

During the inspection, FDA says its investigator "observed rodent feces throughout [the] facility," including near the filling machine the company uses to manufacture OTC drug products and near raw materials and finished drug products.

FDA also says the firm failed to clean and maintain some of its equipment used in the production of OTC drugs, including visible residue build-up in tanks and damaged hoses "held together with plastic wrap." In one instance, FDA says a hinge on the lid of one of the tanks at the facility broke when an employee attempted to open it.

According to FDA, Bicooya also failed to test some lots of its product for active ingredient content and microorganisms.

And, in addition to not being able to provide batch records for some of its products, FDA says its investigator witnessed staff "altering information in analytical tests during the inspection." In one example, FDA says an employee altered the analytical testing report for a lot of an ointment that had already been distributed to the US.

As a result of these issues, FDA says the company should hire a good manufacturing practice consultant and instructs the company to conduct an investigation into its data integrity practices.


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