FDA: 3 companies in cities within Broward County received 11 citations in Q4 2023

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

By South Broward News

Jan 21, 2024

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

This is a 72.7% decrease from the number of companies cited in the previous quarter.

Of the 11 citations issued, the most common citation was 'Procedures for training and identifying training needs have not been adequately established'.

All of the companies cited were involved in the Devices sector.

All of the 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.

Companies located within Broward County Cities and the citations they received in Q4 2023

Company Name	Area of Business	Inspection Date	Issue Cited
Curonix, LLC	Devices	11/08/2023	Software validation for automated processes
Curonix, LLC	Devices	11/08/2023	Procedures for product review,disposition lack of/inadequate
Curonix, LLC	Devices	11/08/2023	Lack of or inadequate procedures
Curonix, LLC	Devices	11/08/2023	Lack of or inadequate complaint procedures
EOSolutions, Corp.	Devices	12/07/2023	Quality audits - Lack of or inadequate procedures
EOSolutions, Corp.	Devices	12/07/2023	Training - Lack of or inadequate procedures
Spineup, Inc.	Devices	10/31/2023	Quality audits - auditor independence
Spineup, Inc.	Devices	10/31/2023	Training - Lack of or inadequate procedures
Spineup, Inc.	Devices	10/31/2023	Acceptable supplier records, inadequate records
Spineup, Inc.	Devices	10/31/2023	Lack of or inadequate final acceptance procedures
Spineup, Inc.	Devices	10/31/2023	Nonconforming product, Lack of or inadequate procedures