Drug factory · FDA FEI 3006896373

Petnet Solutions, Inc.

3728 PHILLIPS HWY STE 221, Jacksonville, FL, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 27, 2026.

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

3 drug inspections on record since 2011: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Flotufolastat F-18	Makes it	Blue Earth Diagnostics	69932-002
Fluciclovine F-18	Makes it	Blue Earth Diagnostics	69932-001
Fluoroestradiol F-18	Makes it	GE Healthcare Inc.	72874-001
Piflufolastat F-18	Makes it	Progenics Pharmaceuticals, Inc.	71258-022

Ended	Result	Program	Problems noted
Feb 27, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	5
Jul 17, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 14, 2011	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.

Oversight of production operations 21 CFR 212.20(a)
You did not oversee production operations in a manner to ensure that each PET drug meets the requirements of the FD&C Act as to safety and meets the quality and purity characteristics that it is supposed to have.
Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is suitable for its intended purposes and 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.
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.
ID of major equipment 21 CFR 212.50(c)(7)
Your batch production record did not include the identification of major pieces of equipment used in production of the batch.
Test records complete (general) 21 CFR 212.60(g)
Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays.

Registered with FDA for: positron emission tomography drug production.