Drug factory · FDA FEI 3007134238

Petnet Solutions, Inc.

4050 E COTTON CENTER BLVD STE 79, Phoenix, AZ, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 8, 2023.

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: 2 with no problems, 2 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
Sep 8, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	3
Aug 19, 2022	No problems found	Drug Quality Assurance	—
Oct 21, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	2
Sep 13, 2012	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

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 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.
Non-Conforming Product Investigation Incomplete 21 CFR 212.71(a)
The investigation of the cause of the nonconforming batch of a PET drug product did not include examination of the processes, operations and other relevant sources of information concerning the nonconforming product.

ID testing - components 21 CFR 212.40(c)(1)(ii)
You did not conduct identity testing on each lot of component that yields an active ingredient in a PET drug product for which you did not conduct finished product testing to ensure that the correct components were used.
Results of investigations 21 CFR 212.50(c)(11)
Your batch production and control records did not include the results of any investigations conducted.

Registered with FDA for: positron emission tomography drug production.