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483
•Jiangxi Synergy Pharmaceutical, Co., Ltd.•January 10, 2019

Jiangxi Synergy Pharmaceutical, Co., Ltd. – FDA 483, Jan 10, 2019

Record Details

Jiangxi Synergy Pharmaceutical, Co., Ltd. in Yichun, P.R. China, was inspected from January 7-10, 2019. The inspection revealed a significant concern regarding the inadequate assurance that water samples are representative of the water used in active pharmaceutical ingredient production. This issue stems from quality control personnel collecting samples from an unsanitized and uncleaned pipe not included in the water system's sanitation loop.

Company
Jiangxi Synergy Pharmaceutical, Co., Ltd.
Inspection date
January 10, 2019
Product type
drugs
Office
Office of Inspections and Investigations
Person
  • Nicholas L. Hunt (Senior CSO, Investigator)
View Company Profile

ID · 593f05b9-a0ab-4103-adf1-cf723591f6e9

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