# FDA 483 - Johns Hopkins University PET Center - September 02, 2016

Source: https://www.globalkeysolutions.net/records/483/johns-hopkins-university-pet-center/626fd257-43cc-4470-8a61-b270d0cd0f16

> FDA 483 for Johns Hopkins University PET Center on September 02, 2016. 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: 2016-09-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Johns Hopkins University PET Center in Baltimore, MD, a PET drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate master production records with component lot number discrepancies, failure to ensure reliable suppliers for media, and a lack of proper procedures for equipment calibration and temperature monitoring in incubators, leading to temperature excursions. These issues indicate a need for improved quality control and record-keeping practices.

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## Related Officers

- [Erik T Ognoskie](https://www.globalkeysolutions.net/people/erik-t-ognoskie/b5ff2b48-e66f-4f30-94f9-c6b932849c41)
- [investigator](https://www.globalkeysolutions.net/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e