Drug factory · FDA FEI 3007283829

Petnet Solutions, Inc.

954 GATEWOOD RD NE, Atlanta, GA, United States

Problems found, fixed voluntarily at FDA's last inspection, Mar 2, 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 2011: 1 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
Mar 2, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	2
Oct 15, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 20, 2013	No problems found	Drug Quality Assurance	—
Feb 7, 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.

Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is cleaned, 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.

Registered with FDA for: positron emission tomography drug production.