Drug factory · FDA FEI 3029778311

Pharmalogic Los Angeles, LLC

2250 Alcazar St, Los Angeles, CA, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 5, 2026.

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

1 drug inspection on record since 2026: 0 with no problems, 1 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
Flurpiridaz F-18	Makes it	GE Healthcare Inc.	0407-8787
Flutemetamol F-18	Makes it	Medi-Physics Inc. dba GE Healthcare.	17156-067
Piflufolastat F-18	Makes it	Progenics Pharmaceuticals, Inc.	71258-022

Ended	Result	Program	Problems noted
Feb 5, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	1

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

Specifications and processes 21 CFR 212.20(c)
You did not approve or reject, before implementation, processes or procedures to ensure that they maintain the identity, strength, quality, and purity of a PET drug.

Registered with FDA for: positron emission tomography drug production.