FDA 483 - Petnet Solutions Inc. - September 26, 2025

During an FDA inspection conducted from September 24-26, 2025, PETNET Solutions Inc., a PET Drug Manufacturer located in Indianapolis, IN, received an FDA Form 483 detailing critical observations. The primary issue identified was a lack of adequate production and process controls necessary to ensure the consistent manufacturing of sterile PET drug products that meet established standards of identity, strength, quality, and purity. Specifically, the company failed to implement sufficient environmental monitoring controls for aseptic operations. Investigators observed that manipulator arms, used for aseptic manipulations within ISO areas of hot cells, were not included in environmental monitoring sampling. Furthermore, the firm's established action limits for microbial contamination in these critical aseptic processing areas were deemed insufficiently stringent. These findings indicate deficiencies in maintaining the sterile environment required for drug production. To ensure compliance with federal regulations, particularly those under the Federal Food, Drug and Cosmetic Act, PETNET Solutions Inc. is required to promptly address these observations by enhancing their environmental monitoring procedures to include all critical aseptic contact points and by establishing appropriately stringent microbial action limits to safeguard product quality and patient safety.