Drug factory · FDA FEI 3006246010

SOFIE Co. dba SOFIE

5900b Obata Way, Gilroy, CA, United States

Problems found, fixed voluntarily at FDA's last inspection, Aug 7, 2025.

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 2014: 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
Aug 7, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	3
Feb 5, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	4
Aug 4, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	1
Feb 14, 2014	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.

Personnel not qualified 21 CFR 212.10
You lack personnel with the necessary training to perform their assigned functions.
Equipment procedures 21 CFR 212.30(b)
You did not implement 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.
Data and documentation review 21 CFR 212.70(d)(2)
You did not establish procedures to ensure that each batch or sub-batch of a PET drug product was not given final release until associated laboratory data and documentation were reviewed and PET drug products were demonstrated to meet specifications.

Personnel not qualified 21 CFR 212.10
You lack personnel with the necessary training to perform their assigned functions.
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.
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.
Final dated signature 21 CFR 212.70(d)(3)
You did not follow procedures to ensure that each batch or sub-batch of a PET drug was not given final release until a designated qualified individual authorized the final release by dated signature.

Investigation of nonconforming product 21 CFR 212.71(b)
You did not completely document the investigation of a PET drug product that did not meet specifications.

Registered with FDA for: positron emission tomography drug production.