# FDA 483 - Washington University School of Medicine - June 14, 2019

Source: https://www.globalkeysolutions.net/records/483/washington-university-school-of-medicine/5ed39a63-482f-4d91-8953-cb2ceaec627d

> FDA 483 for Washington University School of Medicine on June 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Washington University School of Medicine
- Inspection Date: 2019-06-14
- 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, revealed significant deficiencies in their manufacturing operations. The firm failed to establish adequate process controls, validate methods and processes, manage facility changes, and ensure proper laboratory and production oversight. These issues indicate a broad lack of adherence to good manufacturing practices, potentially impacting product quality and safety.

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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