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 3003028650.
Observations4
Issue DateAugust 07, 2025
StatusNo Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections6
Establishment Details
Firm
Sumitomo Pharma Co., Ltd.
Location
Suzuka, -, Japan
FEI Number
3003028650
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
August 07, 2025
Country
Japan
Inspection History, 2012 to 2025
NAI1
VAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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