# FDA 483 - Hamamatsu/Queen's PET Imaging Center, LLC - October 11, 2024

Source: https://www.globalkeysolutions.net/records/483/hamamatsuqueens-pet-imaging-center-llc/897720e3-0549-4d4c-8f7b-c3d3a6391da1

> FDA 483 for Hamamatsu/Queen's PET Imaging Center, LLC on October 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hamamatsu/Queen's PET Imaging Center, LLC
- Inspection Date: 2024-10-11
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: Hamamatsu/Queen's PET Imaging Center, LLC, a PET drug manufacturer in Honolulu, HI, was cited for significant deficiencies during an FDA inspection. Observations included inadequate facilities for contamination prevention due to unjustified environmental monitoring action limits and a lack of procedures to differentiate fungal from bacterial CFU. Additionally, the firm failed to adequately qualify vendors for microbiological media and did not conduct thorough investigations or implement effective corrective actions for out-of-calibration equipment affecting multiple batches.

## Related Officers

- [Crystal Monroy](https://www.globalkeysolutions.net/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

Company: https://www.globalkeysolutions.net/companies/hamamatsuqueens-pet-imaging-center-llc/6bd30513-0893-4eba-93e3-101e293bd64a

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df