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Xiamen Wally Bath Manufacture Co., Ltd., an OTC drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company failed to conduct identity testing on incoming raw materials, instead relying solely on supplier certificates of analysis, and did not test incoming ethanol lots for methanol content or establish specifications for allowable methanol limits. These violations of 21 CFR 211.84(d)(1) were identified through FDA's review of records submitted in response to section 704(a)(4) requests made in June and July 2022.