Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3004055563.
Observations10
Issue DateNovember 21, 2025
Status1 Related Warning Letter
Related Inspections6
Establishment Details
Firm
Sato Pharmaceutical Co., Ltd.
Location
Hachioji, -, Japan
FEI Number
3004055563
Product Type
Drugs
Issue Date
November 21, 2025
Country
Japan
Inspection History, 2012 to 2025
NAI2
VAI2
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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