FDA 483 - PETNET Solutions Inc. - November 04, 2025

During an FDA inspection conducted from October 22 to November 4, 2025, a firm producing PET drug products received a Form 483, identifying significant manufacturing and quality control deficiencies. The observations highlight a systemic failure to adhere to Good Manufacturing Practices.

Key violations include inadequate investigations into unexplained anomalies during residual solvent testing, such as unknown chromatographic peaks, and insufficient root cause analysis for equipment excursions related to temperature and humidity. The firm also lacked proper written procedures to justify deviations from production and process controls, exemplified by an unvalidated drying time for a product transfer line and improper handling of sterile cleaning wipes.

Facility inadequacies were noted, including cracked plexiglass in a Laminar Flow Hood, deficient airflow studies, flaking paint, and a backlog in Quality Assurance review of critical equipment certifications. Furthermore, equipment qualification procedures were found lacking, with temperature-controlled cabinets improperly exempted from mapping and critical refrigerators inadequately validated. Finally, the firm failed to follow its own quality assurance procedures, specifically regarding supplier approval and aseptic gowning techniques, which may contribute to recurring microbial contamination in the sterile environment. The firm is required to address these observations to ensure compliance with regulatory standards and product quality.