# FDA 483 - Northland Nuclear Medicine, LLC - July 13, 2023

Source: https://www.keypedia.com/records/483/northland-nuclear-medicine-llc/cd39eea9-dac5-410d-8946-c84759f1aa49

> FDA 483 for Northland Nuclear Medicine, LLC on July 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northland Nuclear Medicine, LLC
- Inspection Date: 2023-07-13
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Northland Nuclear Medicine, LLC, a PET drug manufacturer in Bismarck, ND, received an FDA Form 483 citing significant deficiencies in its operations. The inspection revealed inadequate production and process controls, including a lack of environmental and personnel monitoring during aseptic manipulations and insufficient equipment cleaning procedures. Additionally, the firm's master production records failed to specify action limits for radiochemical yield.

## Related Documents

- [EIR - 2019-06-07](https://www.keypedia.com/records/eir/northland-nuclear-medicine-llc/2e1bf41b-abbb-49ea-a9ae-a01438c3946b)
- [483 - 2019-06-07](https://www.keypedia.com/records/483/northland-nuclear-medicine-llc/7a92875d-0ef0-44bc-b02c-acbc7e748a4c)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.keypedia.com/companies/northland-nuclear-medicine-llc/ea5b0f88-b6c0-4949-ad0d-aaa0d0e6fbd4

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d