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Facility profile

SOFIE Co. dba SOFIE

FDA-registered facility · Dallas, TX

FDA recordFDA directory updated Jul 21, 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 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Apr 21, 2026 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

Understand this record

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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, Oct 2013 – Apr 2026 · 0 NAI · 4 VAI · 0 OAI

DateClassProject areaCitationsFY
Apr 21, 2026VAIDrug Quality AssuranceYes2026
Jan 15, 2019VAIDrug Quality AssuranceYes2019
May 27, 2016VAIDrug Quality Assurance2016
Oct 22, 2013VAIDrug Quality Assurance2014

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

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

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

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