Drug factory · FDA FEI 3006577728

Petnet Solutions, Inc.

350 WASHINGTON ST UNIT 268, Woburn, MA, United States

Problems found, fixed voluntarily at FDA's last inspection, Nov 4, 2025.

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 2012: 0 with no problems, 4 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
Nov 4, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	5
Jul 28, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	1
Mar 3, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 25, 2012	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 conduct an investigation and take appropriate corrective actions when necessary.
Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures.
Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.
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.
Written control procedures 21 CFR 212.50(a)
You did not have written production and process control procedures to ensure that any deviations from the procedures are justified.

Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is cleaned and suitable for its intended purposes 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.