NC Florida News

There were two companies in a city associated with Alachua 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.

Of the 22 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

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

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Exactech, Inc.	Devices	09/26/2023	Report of Death or Serious Injury
Exactech, Inc.	Devices	09/26/2023	Lack of or inadequate procedures
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Lack of System for Determining MDR Events
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Management representative
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Management review - Lack of or inadequate procedures
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Quality audits - Lack of or inadequate procedures
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Personnel
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Design validation - Risk analysis
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Design validation - software validation documentation
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Documentation of software validation
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Lack of or inadequate procedures
LifeSouth Community Blood Centers, Inc.	Biologics	11/09/2023	Documentation
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Lack of System for Determining MDR Events
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Management representative
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Management review - Lack of or inadequate procedures
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Quality audits - Lack of or inadequate procedures
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Personnel
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Design validation - Risk analysis
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Design validation - software validation documentation
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Documentation of software validation
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Lack of or inadequate procedures
LifeSouth Community Blood Centers, Inc.	Devices	11/09/2023	Documentation