Source: FDA, document on fileFDA 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 this against FDA, open FDA's record for this establishment on FDA's Data Dashboard, which lists this inspection under FEI 3002806419.
Simtra Deutschland GmbH
Halle (Westf.), -, Germany
Issue DateSeptember 26, 2025
FEI Number3002806419
CountryGermany
Status
1 Related Warning Letter
Product Type
Drugs
Establishment Type
Drug Manufacturer
Simtra Deutschland GmbH FDA Form 483, Halle (Westf.), September 26, 2025
