# FDA 483 - Shanghai Techwell Biopharmaceutical Co.,Ltd. - March 11, 2019

Source: https://www.globalkeysolutions.net/records/483/shanghai-techwell-biopharmaceutical-coltd/df03b471-7654-4fc6-a947-91cb4d5139f0

> FDA 483 for Shanghai Techwell Biopharmaceutical Co.,Ltd. on March 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Techwell Biopharmaceutical Co.,Ltd.
- Inspection Date: 2019-03-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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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Company: https://www.globalkeysolutions.net/companies/shanghai-techwell-biopharmaceutical-coltd/c82ebf7e-0fe8-4f2c-939f-2ee447dc8377

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1