# FDA 483 - The Feinstein Institute for Medical Research - May 09, 2025

Source: https://www.globalkeysolutions.net/records/483/the-feinstein-institute-for-medical-research/9edd5976-ce7f-4f83-a1fb-2f775df96247

> FDA 483 for The Feinstein Institute for Medical Research on May 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Feinstein Institute for Medical Research
- Inspection Date: 2025-05-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The FDA inspected The Feinstein Institute for Medical Research, a PET drug manufacturer, and found significant deficiencies. The firm lacked established written quality assurance procedures for critical operations such as supplier qualification, component handling, and product distribution. Additionally, the inspection revealed severe data integrity issues in the laboratory, where radiochemists had administrative privileges to alter or delete product release testing data.

## Related Documents

- [483 - 2025-05-09](https://www.globalkeysolutions.net/records/483/the-feinstein-institute-for-medical-research/89eb14db-25c2-4be8-bd1c-6227274c629b)

## Related Officers

- [Tanya R. Syffrard](https://www.globalkeysolutions.net/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)
- [Investigator](https://www.globalkeysolutions.net/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.globalkeysolutions.net/companies/the-feinstein-institute-for-medical-research/8dbe37c5-ac4e-438d-899f-218c4fbeb36a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961