FDA 483 - PETNET Solutions Inc - February 17, 2026

During an inspection conducted from February 9 to February 17, 2026, the FDA identified several significant quality and safety violations at the PETNET Solutions Inc. manufacturing facility in Cleveland, Ohio. The inspection, conducted under the Federal Food, Drug, and Cosmetic Act, revealed critical deficiencies in the company’s ability to maintain a sterile environment for manufacturing PET drug products.

Key issues included a failure to investigate or perform corrective actions after pathogenic fungal organisms were discovered in high-grade sterile production areas. The firm’s environmental monitoring program was found to be incomplete, as it lacked routine testing for supporting rooms and failed to verify the effectiveness of cleaning procedures through resampling. Furthermore, the FDA noted that essential equipment, such as incubators used for sterility testing, had not undergone proper temperature mapping to ensure accuracy. Design flaws in the ventilation systems near sterile hoods and a lack of continuous air pressure monitoring were also cited as risks to product purity.

Additional violations involved inadequate process controls for reprocessed radioactive materials and the use of equipment that was not qualified for required temperature ranges. While these observations do not constitute a final regulatory determination, PETNET Solutions is required to address these findings. The firm must implement a corrective and preventive action (CAPA) plan and submit a formal response to the FDA detailing their steps to resolve these issues and ensure future compliance with safety standards.