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 3010668881.
Observations3
Issue DateJune 12, 2025
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Gunze Limited
Location
Ayabe
FEI Number
3010668881
Product Type
Devices
Issue Date
June 12, 2025
Country
N/A
Inspection History, 2018 to 2025
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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