PETNET Solutions, Inc. – FDA 483, Mar 6, 2026

From March 4 to March 6, 2026, the Food and Drug Administration (FDA) conducted an inspection of PETNET Solutions, Inc., a positron emission tomography (PET) drug manufacturer located in Las Vegas, Nevada. The inspection identified several critical issues regarding the facility"s production controls and quality assurance practices. A primary concern involved inadequate process controls to ensure drug quality and purity. Specifically, the FDA noted inconsistencies in how technicians performed bacterial endotoxin testing. The lack of detailed instructions for sample handling—such as the timing and method for mixing samples before testing—created a risk for inaccurate results. Furthermore, the facility failed to implement a necessary quarantine period for final product vial subassemblies. This oversight allowed materials to be used in drug manufacturing before environmental monitoring results were finalized. In one instance, vials were used despite subsequent reports showing significant bacterial growth on an operator"s glove. Additionally, the inspection found that staff failed to strictly follow established quality assurance procedures. During the site visit, an operator was observed performing environmental monitoring of their gloves incorrectly, failing to follow the precise sampling techniques required by the company’s internal protocols. These observations were issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act to assist the firm in reaching compliance. PETNET Solutions is required to review these findings and submit a formal response to the FDA. This response should outline the corrective actions taken or planned to resolve the identified deficiencies and prevent their recurrence. While this document is not a final determination of compliance, it serves as a formal notice of conditions that could lead to drug contamination or health risks.