PETNET Solutions, Inc – FDA EIR, Jun 15, 2022

An FDA Pre-approval Inspection of PETNET Solutions, Inc. in Portland, Oregon, was conducted from June 13 to June 15, 2022. This abbreviated inspection focused on the company's production of specific sterile drug products and related activities, operating under the regulatory framework of cGMP for PET Drugs (21 CFR Part 212) and the Food Drug & Cosmetic Act. The inspection, performed under CP 7356.002P, covered critical systems including Quality, Aseptic Sterility Control, and Production. Investigators reviewed production records, investigations, change controls, deviations, and observed sampling and testing procedures for a specific batch. The assessment included a thorough review of the quality system, which revealed no significant issues such as sterility-positive test results, product recalls, or media fill failures since the last inspection. Although there were fifteen out-of-specification test results over two years, a random review indicated no significant concerns. Crucially, the inspection concluded with no significant deficiencies noted, and an FDA-483, a form listing observations of objectionable conditions, was not issued. Consequently, no specific regulatory violations were identified, and no formal required actions were mandated. During the closeout meeting, management was thanked for their cooperation and cautioned to continually review and apply relevant regulations to their operations.