483
Shanghai Techwell Biopharmaceutical Co.,Ltd.FDA 483 - Shanghai Techwell Biopharmaceutical Co.,Ltd. - March 11, 2019
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Record Details
An FDA inspection of Shanghai Techwell Biopharmaceutical, a manufacturer in Shanghai, CN, identified one observation. The firm was cited for deficiencies in its batch record documentation, specifically regarding the recording of calculations, units of measure, and conversion factors for an intermediate product. This indicates issues with data integrity and quality control processes.
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