Larimer News

There were two companies in cities associated with Larimer County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county were 'There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed' and 'Failure to determine the eligibility of the donor by performing a physical assessment of the donor before collection'.

Both companies cited should take voluntary actions to correct their managing operations.

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
Biolife Plasma Services L. P.	Biologics	05/18/2023	Physical Assessment of Donor
Tolmar, Inc.	Drugs	01/31/2023	Investigations of discrepancies, failures