Lee Today

There were two companies in a city associated with Lee County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2024, 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 quarter.

The citations in the county were 'The responsibilities and procedures applicable to the quality control unit are not fully followed' and 'Donors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases'.

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
Prestige Packaging	Drugs	07/18/2024	Procedures not in writing, fully followed
Specialists in Reproductive Medicine & Surgery, P. A.	Biologics	08/14/2024	Risk factors, clinical evidence