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Sofie Co Dba Sofie

FDA Regulatory Profile

Sofie Co Dba Sofie has 1 FDA recall, 45 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest recall
D-1177-2023 · Class II · Aug 22, 2023
Latest inspection
Apr 21, 2026 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections45Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

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…Aug 22, 2023

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 21, 2026Dallas, TXDrugsVoluntary Action Indicated (VAI)3008486071
Jan 15, 2026Decatur, ILDrugsVoluntary Action Indicated (VAI)3009754344
Oct 28, 2025Houston, TXDrugsVoluntary Action Indicated (VAI)3003932395
Sep 3, 2025Kansas City, MODrugsVoluntary Action Indicated (VAI)3008310003
Aug 28, 2025Morgantown, WVDrugsVoluntary Action Indicated (VAI)3005705842
Aug 7, 2025Gilroy, CADrugsVoluntary Action Indicated (VAI)3006246010
Jul 25, 2025Sterling, VADrugsVoluntary Action Indicated (VAI)3004977184
Jul 12, 2024Romeoville, ILDrugsVoluntary Action Indicated (VAI)3008297570
Jan 22, 2024Sanford, FLDrugsVoluntary Action Indicated (VAI)3008302967
Aug 11, 2023Totowa, NJDrugsVoluntary Action Indicated (VAI)3008415560
Jan 20, 2023Somerset, NJDrugsVoluntary Action Indicated (VAI)3005705951
Sep 22, 2021Sanford, FLDrugsOfficial Action Indicated (OAI)3008302967
Apr 12, 2019Sanford, FLDrugsOfficial Action Indicated (OAI)3008302967
Feb 5, 2019Gilroy, CADrugsVoluntary Action Indicated (VAI)3006246010
Jan 22, 2019Kansas City, MODrugsVoluntary Action Indicated (VAI)3008310003
Jan 15, 2019Dallas, TXDrugsVoluntary Action Indicated (VAI)3008486071
Dec 3, 2018Sterling, VADrugsVoluntary Action Indicated (VAI)3004977184
Jun 28, 2017Totowa, NJDrugsNo Action Indicated (NAI)3008415560
Jan 4, 2017Houston, TXDrugsNo Action Indicated (NAI)3003932395
Aug 17, 2016Decatur, ILDrugsNo Action Indicated (NAI)3009754344

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3008486071Dallas, TX4Apr 21, 2026
FEI 3009754344Decatur, IL4Jan 15, 2026
FEI 3003932395Houston, TX4Oct 28, 2025
FEI 3008310003Kansas City, MO4Sep 3, 2025
FEI 3005705842Morgantown, WV4Aug 28, 2025
FEI 3006246010Gilroy, CA4Aug 7, 2025
FEI 3004977184Sterling, VA5Jul 25, 2025
FEI 3008297570Romeoville, IL4Jul 12, 2024
FEI 3008302967Sanford, FL4Jan 22, 2024
FEI 3008415560Totowa, NJ4Aug 11, 2023
FEI 3005705951Somerset, NJ4Jan 20, 2023

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.