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FDAnews Drug Daily Bulletin

FDA Warns Chinese OTC Drugmaker

Feb. 5, 2019

The FDA hit Hangzhou Guogang Touring Commodity, an OTC drug manufacturer in Zhejiang, China, with a warning letter, for significant problems with equipment cleaning and drug product conformity.

In April 17 to 20, 2018 inspection of the facility, investigators found that the company manufactured both OTC and non-drug products on shared equipment but didn’t conduct proper validation studies to ensure there was no cross-contamination. The company failed to provide enough information about its corrective action to validate current cleaning procedures for non-dedicated equipment, the agency said.

The company also distributed lots of product to the U.S. without testing the identity, strength, quality and purity of the active ingredients. In addition, the facility lacked a proper stability testing program. The agency requested stability test results for all OTC drug products the firm distributed in the U.S. within the expiration date.

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