Manufacturing sites in Germany and China hit with warning letters over QC and cleaning issues
Two separate drug manufacturers have been cited by US regulators over several infractions including quality, cleaning and other issues.
The FDA on Tuesday released two warning letters to Chinese API producer Zhejiang Tianyu Pharmaceutical Co and Germany-based OTC drug manufacturer SystemKosmetik.
The letter issued to SystemKosmetik earlier this month stated that the company’s facility in Munster, Germany has several cGMP violations against it such as not having written procedures for production and process control and no written procedures for equipment cleaning and maintenance where the company makes its OTC products.
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