Drug factory · FDA FEI 3008486071

SOFIE Co. dba SOFIE

4447 Brass Way, Dallas, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, Apr 21, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

4 drug inspections on record since 2013: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Florbetaben F-18	Makes it	Lantheus Biosciences Ltd., a Lantheus company	54828-001
Fludeoxyglucose F-18	Makes it	SOFIE Co. dba SOFIE	49609-101
Fluoride Ion F-18	Makes it	SOFIE Co. dba SOFIE	49609-102
Flurpiridaz F-18	Makes it	GE Healthcare Inc.	0407-8787
Piflufolastat F-18	Makes it	Progenics Pharmaceuticals, Inc.	71258-022

Ended	Result	Program	Problems noted
Apr 21, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jan 15, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	5
May 27, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 22, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Equipment procedures 21 CFR 212.30(b)
You did not implement procedures and document your activities in accordance with your procedures to ensure that all equipment is cleaned and suitable for its intended purposes that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.

Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.
Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Initials, signature, date 21 CFR 212.60(g)(5)
Laboratory test records did not contain the initials or signature of the person performing the test.
When 30 hour rule is exceeded 21 CFR 212.70(e)
A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer period did not adversely affect the sample and that the test results obtained were equivalent to test results that would have been obtained if the test had been started within the 30 hour period.

Registered with FDA for: positron emission tomography drug production.