PETNET Solutions, Inc. – FDA 483, Sep 2, 2025

From August 26 to September 2, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of PETNET Solutions, Inc., a PET manufacturer located in North Wales, PA. The inspection resulted in the issuance of an FDA Form 483, detailing an observation of concerning practices.

The primary issue identified was that the company's facilities were deemed inadequate to ensure the prevention of contamination of equipment or product. Specifically, during environmental monitoring of ISO areas in the hot cells, FDA investigators observed that the lids of settle plates were partially covering the plates. This practice deviates from the company's own standard operating procedure (SOP D0012139), which requires the lid to be propped up without covering the plate. The FDA noted that allowing the lid to cover a portion of the plate could prevent contaminants from settling properly, potentially leading to falsely low environmental monitoring results and compromising product quality.

This FDA Form 483 serves as an official communication of inspectional observations, highlighting conditions that may indicate non-compliance with the Federal Food, Drug, and Cosmetic Act. PETNET Solutions, Inc. is now expected to review these observations and submit a comprehensive response outlining corrective actions implemented or planned to address the identified deficiencies and ensure regulatory compliance.