Sofie Co dba Sofie

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
5
Compliance Actions
1

Known Names

sofie co. dba sofie, sofie co dba sofie

Recent Recalls

NumberClassProductDate
D-1177-2023Class IIFlorbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial,August 22, 2023