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# 2 WuXi FDA-483s Released
- URL: https://www.fdaweb.com/2-wuxi-fda-483s-released/
- Published: 2022-03-16T12:00:00.000Z
- Updated: 2026-09-14T17:36:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151372

FDA has released the FDA-483s issued following two 3/22-4/2/21 inspections at WuXi Biologics Co., a WuXi, Jiangsu, China, drug substance and drug product manufacturer. The first [FDA-483](http://www.fda.gov/media/156918/download?ref=fdaweb.com) has these five observations: 

- failing to exercise appropriate controls over computer or related systems to prevent changes to data;
- deficient quality unit oversight over the issuance of controlled documents;
- failing to establish adequate schedules for equipment preventive maintenance;
- deficient specifications for components used in the production of drug substances in that they do not include a description of the sampling plan; and
- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed.

The second [FDA-483](http://www.fda.gov/media/156917/download?ref=fdaweb.com) has these three observations: 

- failing to fully follow the responsibilities and procedures applicable to the quality control unit for material suppliers;
- failing to take corrective actions when data from critical quality attributes indicate a trend towards out-of-specification; and
- failing to retain the amount of samples sufficient to perform all tests, except for endotoxin and sterility, in duplicate.

Following the 2021 inspections, the company had issued a [statement](https://www.fdaweb.com/wuxi-biologics-completes-2-fda-inspections/) that it successfully completed both an FDA pre-license inspection and a routine FDA good manufacturing practice inspection focused on two innovative biologics. The company said that over the 15 working days, nine agency inspectors evaluated the manufacturing, raw material, warehousing, laboratory, equipment, utilities, and quality systems in a combination of on-site and virtual inspections using digital solutions developed by the company.