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Facility profile

SOFIE Co. dba SOFIE

FDA-registered facility · Sanford, FL

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed13 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

Positron Emission Tomography Drug Production
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 22, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Jan 22, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2019

More than five years old · review later records.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history4 inspection records

FDA inspection history

4 records, Aug 2014 – Jan 2024 · 0 NAI · 2 VAI · 2 OAI

DateClassProject areaCitationsFY
Jan 22, 2024VAIDrug Quality AssuranceYes2024
Sep 22, 2021OAIDrug Quality Assurance2021
Apr 12, 2019OAIDrug Quality AssuranceYes2019
Aug 5, 2014VAIDrug Quality Assurance2014

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Oct 10, 2019Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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