Drug factory · FDA FEI 3008203744

Petnet Solutions, Inc.

7048 S 188TH ST BLDG 1, Kent, WA, United States

Problems found, fixed voluntarily at FDA's last inspection, Apr 18, 2025.

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

5 drug inspections on record since 2010: 0 with no problems, 5 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
Apr 18, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jul 30, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	1
Apr 16, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 7, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 3, 2010	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 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.

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

Registered with FDA for: positron emission tomography drug production.