FDA EIR - PETNET Solutions, Inc. - February 21, 2020

An FDA Pre-Approval Inspection of PETNET Solutions, Inc.'s Loma Linda facility occurred from February 18-21, 2020. Conducted under the Positron Emission Tomography (PET) CGMP Drug Process and Pre-Approval Inspections/Investigations Compliance Program, the inspection aimed to support a New Drug Application review. The agency issued a three-item Form FDA-483 for objectionable conditions. Main violations included a lack of adequate production and process controls, specifically that media fill procedures for operator qualification did not include a critical manufacturing step, referencing 21 CFR 212.50. Additionally, the firm did not implement appropriate corrective and preventive actions for identified quality issues, such as environmental monitoring investigations lacking comprehensive CAPAs for recurring microbial growth and a deviation investigation failing to identify all impacted product lots, violating 21 CFR 212.71(C). The third observation noted the use of components past their expiration date. PETNET Solutions' management committed to providing a written response to the FDA within 15 business days.