# FDA 483 - Johns Hopkins University PET Center - April 19, 2024

Source: https://www.globalkeysolutions.net/records/483/johns-hopkins-university-pet-center/ad5fe426-6cb0-492f-82e6-b4bbbbe1e454

> FDA 483 for Johns Hopkins University PET Center on April 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johns Hopkins University PET Center
- Inspection Date: 2024-04-19
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Johns Hopkins University PET Center in Baltimore, MD, a PET drug manufacturer, revealed significant deficiencies in quality control. Observations included inadequate environmental monitoring for sterile drug production, lack of procedures for component examination and approval, and insufficient cleaning procedures and documentation for equipment. These issues raise concerns about the quality and purity of their sterile injectable radioactive drug products.

## Related Documents

- [483 - 2016-09-02](https://www.globalkeysolutions.net/records/483/johns-hopkins-university-pet-center/626fd257-43cc-4470-8a61-b270d0cd0f16)

## Related Officers

- [Evan Tong](https://www.globalkeysolutions.net/people/evan-tong/2cd81562-886c-4672-9522-a07fb1b33ef2)
- [issuing_officer](https://www.globalkeysolutions.net/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.globalkeysolutions.net/companies/johns-hopkins-university-pet-center/184f7e43-e0b8-4314-a1df-0341eadb9ce5

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64