# FDA 483 - Northland Nuclear Medicine, LLC - June 07, 2019

Source: https://www.keypedia.com/records/483/northland-nuclear-medicine-llc/7a92875d-0ef0-44bc-b02c-acbc7e748a4c

> FDA 483 for Northland Nuclear Medicine, LLC on June 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northland Nuclear Medicine, LLC
- Inspection Date: 2019-06-07
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Northland Nuclear Medicine, LLC in Bismarck, ND, a manufacturer of PET drugs, revealed significant deficiencies. The firm lacked adequate production and process controls, including issues with aseptic process simulations, data integrity, and vendor qualification. Additionally, critical equipment was not properly qualified, and master production records were incomplete, raising concerns about the consistent quality and purity of their 18F-FDG product.

## Related Documents

- [EIR - 2019-06-07](https://www.keypedia.com/records/eir/northland-nuclear-medicine-llc/2e1bf41b-abbb-49ea-a9ae-a01438c3946b)
- [483 - 2023-07-13](https://www.keypedia.com/records/483/northland-nuclear-medicine-llc/cd39eea9-dac5-410d-8946-c84759f1aa49)

## Related Officers

- [Scott A. Golladay](https://www.keypedia.com/people/scott-a-golladay/78c90066-7212-4442-900c-5cdcb677aeec)
- [Pharmacist at U.S. Public Health Service Commissioned Corps](https://www.keypedia.com/people/anthony-j-ladner/dbb6b53a-80d1-4b47-ae42-6eb2053dfa4b)

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