Quantcast

Larimer News

Wednesday, December 4, 2024

FDA: 1 company in cities within Larimer County received 2 citations in Q1

Webp r4rtnb3h764dx5zlstpe2fag0ycm

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

There was one company in a city associated with Larimer County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2024, 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 quarter.

The citations in the county were 'Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences' and 'Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information'.

The company cited should take a voluntary action to correct its 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.

Companies located within Larimer County Cities and the citations they received in Q1
Company NameArea of BusinessInspection DateIssue Cited
Tolmar, Inc.Drugs02/23/2024Failure to develop written procedures
Tolmar, Inc.Drugs02/23/2024Late submission of 15-day report

ORGANIZATIONS IN THIS STORY

!RECEIVE ALERTS

The next time we write about any of these orgs, we’ll email you a link to the story. You may edit your settings or unsubscribe at any time.
Sign-up

DONATE

Help support the Metric Media Foundation's mission to restore community based news.
Donate

MORE NEWS