North Orlando News

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

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• You did not develop an FSVP.
• You did not establish and maintain procedures for testing and screening of HCT/P donors.
• Donors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.

Most of the companies cited were involved in the Biologics 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Brazilian Pet, LLC.	Veterinary	08/15/2023	Develop FSVP
Fertility Center of Orlando	Biologics	11/21/2023	Testing, screening, donor eligibility procedures
Fertility Center of Orlando	Biologics	11/21/2023	Risk factors, clinical evidence
Kedplasma, LLC	Biologics	06/26/2023	Physician review of four month sample
Nuline Sensors, LLC	Devices	04/25/2023	Lack of Written MDR Procedures
Nuline Sensors, LLC	Devices	04/25/2023	Not approved or obsolete document retrieval
Nuline Sensors, LLC	Devices	04/25/2023	Production processes
Nuline Sensors, LLC	Devices	04/25/2023	Maintenance schedule, Lack of or inadequate schedule
Nuline Sensors, LLC	Devices	04/25/2023	Documentation
Nutrex Research, Inc.	Food and Cosmetics	08/11/2023	Specifications - identity, purity, strength, composition
Nutrex Research, Inc.	Food and Cosmetics	08/11/2023	Written procedures - quality control operations