483
Xinxiang Tuoxin Pharmaceutical Co. LtdXinxiang Tuoxin Pharmaceutical Co. Ltd – FDA 483, Oct 18, 2021
Record Details
Xinxiang Tuoxin Pharmaceutical Co., Ltd., a drug intermediates manufacturer in Xinxiang, China, was cited for significant quality control deficiencies during an FDA inspection. Observations included poorly maintained manufacturing equipment with potential for product contamination, unvalidated laboratory analytical methods, and inadequate investigation of deviations. Furthermore, the firm lacked proper electronic controls for data integrity in computerized systems.
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ID · e3cddd0f-9c6a-43cd-b158-071155413a75
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