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

Source: https://www.keypedia.com/records/483/molecular-imaging-program-at-stanford/f12b5d0d-4d9b-44a7-a8ed-7e2c4f4b5b01

> FDA 483 for Molecular Imaging Program at Stanford on April 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Molecular Imaging Program at Stanford
- Inspection Date: 2026-04-17
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: 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.

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