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 3000234005.
Observations22
Issue DateSeptember 16, 2025
Status1 Related Warning Letter
Establishment TypeSterile Drug Manufacturer
Related Inspections7
Establishment Details
Firm
Fareva Amboise
Location
Poce Sur Cisse, -, France
FEI Number
3000234005
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
September 16, 2025
Country
France
Inspection History, 2010 to 2025
NAI1
VAI5
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.