# FDA 483 - Washington University School of Medicine - March 21, 2024

Source: https://www.globalkeysolutions.net/records/483/washington-university-school-of-medicine/bae6855e-2623-4702-a25c-0be0cd6a4b83

> FDA 483 for Washington University School of Medicine on March 21, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Washington University School of Medicine
- Inspection Date: 2024-03-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Washington University School of Medicine, a PET Drug Manufacturer in St. Louis, MO, identified two repeat observations related to laboratory controls. The firm failed to establish adequate access controls for analytical equipment, allowing deletion of results without audit trails. Additionally, the analytical laboratory lacked consistent criteria and guidelines for manual integrations of GC chromatograms.

## Related Documents

- [483 - 2019-06-14](https://www.globalkeysolutions.net/records/483/washington-university-school-of-medicine/5ed39a63-482f-4d91-8953-cb2ceaec627d)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)
- [Matthew M. Schuckmann](https://www.globalkeysolutions.net/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)

Company: https://www.globalkeysolutions.net/companies/washington-university-school-of-medicine/b4b3b2ae-0529-4621-84f0-f9d4b60a13ef

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8