Central ND News

There was one company in a city associated with Burleigh County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• You did not implement procedures to ensure that all equipment is cleaned that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.
• Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
• Your master production and control records did not include a statement of action limits on radiochemical yield.

The company cited had to take regulatory and/or administrative actions.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Northland Nuclear Medicine, LLC	Drugs	07/13/2023	Equipment procedures
Northland Nuclear Medicine, LLC	Drugs	07/13/2023	Adequate controls (general)
Northland Nuclear Medicine, LLC	Drugs	07/13/2023	Action limits on radiochemical yield