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 3002806419.
Observations112
Issue DateSeptember 26, 2025
Status1 Related Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections10
Establishment Details
Firm
Simtra Deutschland GmbH
Issued To
Baxter Oncology GmbH
Location
Halle (Westf.), -, Germany
FEI Number
3002806419
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
September 26, 2025
Country
Germany
Inspection History, 2011 to 2025
NAI5
VAI4
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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