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www.fdanews.com/articles/195331-chinese-devicemaker-hit-for-testing-deficiencies

Chinese Devicemaker Hit for Testing Deficiencies

December 31, 2019

The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing.

The company, a manufacturer of multiple over-the-counter transdermal patch drug products, including a pain-relieving patch, failed to test finished products for strength and identity before releasing them to the U.S. market, the agency said.

Henan said it planned to hire a third-party testing laboratory to correct the violation, and would begin testing for the active ingredient in each batch of finished drug products it marketed in the U.S. But the FDA called for more details, including a detailed description of the tests.

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