Central Broward News

There were two companies in a city associated with Broward County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 71.4% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• The written MDR Procedure does not include an internal system which provides for timely and effective communication of events that may be subject to medical device reporting requirements.
• Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system with sufficient frequency.
• Quality audits were not performed at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.

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

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
Nutek Orthopaedics, Inc.	Devices	11/19/2024	Lack of System for Event Evaluations
Nutek Orthopaedics, Inc.	Devices	11/19/2024	Management review - defined interval, sufficient frequency
Nutek Orthopaedics, Inc.	Devices	11/19/2024	Quality Audits - defined intervals
Nutek Orthopaedics, Inc.	Devices	11/19/2024	Training - Lack of or inadequate procedures
Nutek Orthopaedics, Inc.	Devices	11/19/2024	Procedures not adequately established or maintained
Nutek Orthopaedics, Inc.	Devices	11/19/2024	Purchasing controls, Lack of or inadequate procedures
Nutek Orthopaedics, Inc.	Devices	11/19/2024	Lack of or inadequate final acceptance procedures
Nutek Orthopaedics, Inc.	Devices	11/19/2024	DHR - not or inadequately maintained
Nutek Orthopaedics, Inc.	Devices	11/19/2024	Devices subject to device identification GUDID data submission requirements.
Precision Align, LLC	Devices	11/07/2024	Justification for not reporting
Precision Align, LLC	Devices	11/07/2024	Design history file
Precision Align, LLC	Devices	11/07/2024	Lack of or inadequate procedures