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Facility profile

SOFIE Co. dba SOFIE

FDA-registered facility · Sterling, VA

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

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Jul 25, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2008

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 history5 inspection records

FDA inspection history

5 records, Aug 2010 – Jul 2025 · 1 NAI · 4 VAI · 0 OAI

DateClassProject areaCitationsFY
Jul 25, 2025VAIDrug Quality AssuranceYes2025
Dec 3, 2018VAIDrug Quality AssuranceYes2019
Jan 23, 2015NAIDrug Quality Assurance2015
Feb 1, 2013VAIDrug Quality Assurance2013
Aug 11, 2010VAIDrug Quality Assurance2010

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

Matched compliance actions

Oct 24, 2008Warning 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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