Sofie Co dba Sofie

FDA Regulatory Profile

Sofie Co dba Sofie appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1177-2023, Class II) was initiated on August 22, 2023.

Summary

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

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