# FDA 483 - Molecular Imaging Program at Stanford - October 04, 2024

Source: https://www.globalkeysolutions.net/records/483/molecular-imaging-program-at-stanford/814e7cf6-f77c-4913-9962-815bbdb21af9

> FDA 483 for Molecular Imaging Program at Stanford on October 04, 2024. 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: 2024-10-04
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Molecular Imaging Program at Stanford revealed significant deficiencies across multiple areas. The firm failed to establish and follow written quality assurance procedures for cGMP training, deviation handling, environmental monitoring, and clean room certification. Additionally, electronic records lacked adequate controls for user access and audit trails, and expired testing materials were found in storage.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)

Company: https://www.globalkeysolutions.net/companies/molecular-imaging-program-at-stanford/2ebff17a-cb06-422f-a1d8-d32bae7f07ed

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df