# Northland Nuclear Medicine, LLC – FDA 483, May 29, 2026

Source: https://www.keypedia.com/records/483/northland-nuclear-medicine-llc/0ee840fc-c882-43b7-9467-3d023f2ae474

> FDA 483 for Northland Nuclear Medicine, LLC on May 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northland Nuclear Medicine, LLC
- Inspection Date: 2026-05-29
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Northland Nuclear Medicine, LLC, a PET Drug Manufacturer in Bismarck, ND, was cited for significant deficiencies during an FDA inspection. The observations included inadequate facilities for preventing contamination, specifically concerning environmental monitoring, aseptic technique, and smoke studies. Additionally, the firm's corrective and preventive action (CAPA) system lacked proper effectiveness checks, and written procedures for ensuring component suitability were found to be inadequate.

## Related Documents

- [WARNING_LETTER - 2026-05-29](https://www.keypedia.com/records/warning_letter/northland-nuclear-medicine-llc/2870b35f-4b1f-4b91-8f23-59968cf54178) — date: May 29, 2026
- [483 - 2023-07-13](https://www.keypedia.com/records/483/northland-nuclear-medicine-llc/cd39eea9-dac5-410d-8946-c84759f1aa49) — date: July 13, 2023
- [483 - 2019-06-07](https://www.keypedia.com/records/483/northland-nuclear-medicine-llc/7a92875d-0ef0-44bc-b02c-acbc7e748a4c) — date: June 7, 2019
- [EIR - 2019-06-07](https://www.keypedia.com/records/eir/northland-nuclear-medicine-llc/2e1bf41b-abbb-49ea-a9ae-a01438c3946b) — date: June 7, 2019

## Related Officers

- [Melissa M. Steiger](https://www.keypedia.com/people/melissa-m-steiger/513a7364-15df-474f-8a8a-b5c4ff1cf59f)
- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)

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