Drug factory · FDA FEI 3009288779

Pharmalogic Puerto Rico, Inc.

150 Calle Federico Costa, San Juan, PR, United States

Problems found, fixed voluntarily at FDA's last inspection, Aug 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: 1 with no problems, 3 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	Precision Nuclear LLC	52768-001
Piflufolastat F-18	Makes it	Progenics Pharmaceuticals, Inc.	71258-022

Ended	Result	Program	Problems noted
Aug 21, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	5
Jan 19, 2018	No problems found	Drug Quality Assurance	—
Jul 22, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	1
Dec 27, 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.

Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary.
Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is properly installed, maintained, and capable of repeatedly producing valid results 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.
Use of reliable suppliers 21 CFR 212.40(c)
You did not use a reliable supplier as a source of each lot of component and container.
Written control procedures 21 CFR 212.50(a)
You did not have written production and process control procedures to ensure and document that all key process parameters are controlled.
Supplies adequately controlled 21 CFR 212.60(d)
Your identity, purity and quality of supplies used in your testing procedures are not adequately controlled.

Correct malfunction, re-do test 21 CFR 212.70(f)(1)(iv)
You approved a conditional final release of a PET drug product batch due to analytical equipment malfunction, but you did not document that reasonable efforts had been made to prevent recurrence of the malfunction.

Registered with FDA for: positron emission tomography drug production.