FDA 483 - Molecular Imaging Program at Stanford - April 17, 2026

The FDA issued a Form 483 to Molecular Imaging Program at Stanford, a PET Drug Manufacturer in Palo Alto, CA, following an inspection. The observations highlight significant deficiencies in quality assurance, including incomplete batch records, inadequate sterility testing, and a lack of written procedures for labeling and equipment maintenance. Additionally, the firm demonstrated insufficient laboratory controls for testing, equipment qualification, and vendor management, indicating systemic failures in adhering to good manufacturing practices.