Pensacola Times

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

This is unchanged from the number of companies cited in the previous year.

The citations in the county include:

• Procedures for design validation have not been adequately established.
• Document control procedures have not been adequately established and maintained.
• Requirements that must be met by suppliers have not been adequately established.

All of the companies cited were involved in either Devices, Veterinary, or Biologics sectors.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Medical Energy, Inc.	Devices	05/17/2023	Design validation- Lack of or inadequate procedures
Medical Energy, Inc.	Devices	05/17/2023	Procedures not adequately established or maintained
Medical Energy, Inc.	Devices	05/17/2023	Evaluation of suppliers, contractors, etc., requirements
Medical Energy, Inc.	Devices	05/17/2023	Lack of or inadequate complaint procedures
OneBlood, Inc.	Biologics	03/21/2023	Equipment observed, standardized, calibrated
Pegasus Laboratories, Inc.	Veterinary	02/24/2023	Procedures not in writing, fully followed
Pegasus Laboratories, Inc.	Veterinary	02/24/2023	Scientifically sound laboratory controls
Pegasus Laboratories, Inc.	Veterinary	02/24/2023	Calibration - at intervals, written program, remedial action
Pegasus Laboratories, Inc.	Veterinary	02/24/2023	Written record of investigation incomplete