Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3012116434.
Observations4
Issue DateSeptember 11, 2025
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Location
Taihu, China
FEI Number
3012116434
Product Type
Devices
Issue Date
September 11, 2025
Country
China
Inspection History, 2016 to 2025
NAI2
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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