# FDA 483 - Hot Shots Nuclear Medicine, LLC - August 09, 2019

Source: https://www.globalkeysolutions.net/records/483/hot-shots-nuclear-medicine-llc/e455cce8-1e27-4ec4-b2ae-c3acd44558ee

> FDA 483 for Hot Shots Nuclear Medicine, LLC on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hot Shots Nuclear Medicine, LLC
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Hot Shots Nuclear Medicine, a PET drug producer in Davenport, IA, revealed significant deficiencies in equipment maintenance, production area cleanliness, and quality control. Observations included issues with the laminar airflow cabinet, use of non-sterile gloves and wipes, lack of environmental monitoring, and failure to investigate unknown peaks in finished drug products. These findings indicate a need for improved controls to ensure the quality and safety of PET drugs.

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- [483 - 2022-02-18](https://www.globalkeysolutions.net/records/483/hot-shots-nuclear-medicine-llc/2a6b5336-088c-42e4-9ee3-9f6b60007bfc)

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.globalkeysolutions.net/companies/hot-shots-nuclear-medicine-llc/a1e275f8-0bd1-42b3-a5cc-1f114829eec8

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