Drug factory · FDA FEI 3008415560

SOFIE Co. dba SOFIE

60H Commerce Way, Totowa, NJ, United States

Problems found, fixed voluntarily at FDA's last inspection, Aug 11, 2023.

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 2012: 2 with no problems, 2 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
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
Aug 11, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	4
Jun 28, 2017	No problems found	Drug Quality Assurance	—
May 15, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 27, 2012	No problems found	Drug Quality Assurance	—

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

Complaint review 21 CFR 212.100(b)
Your complaint procedures do not include an investigation to determine the cause of the failure.
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.
Documentation of Non-Conforming Product Investigation 21 CFR 212.71(b)
You did not document for a PET drug product that did not meet specifications.
Labeling and product mix-ups 21 CFR 212.80(d)
Labeling and packaging operations for PET drug products were not controlled to prevent labeling and product mix-ups.

Registered with FDA for: positron emission tomography drug production.