Tampa Republic

There were three companies in a city associated with Hillsborough County that received FDA citations as a result of three inspections conducted in the county over the fourth quarter of 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 quarter.

The citations in the county include:

• You did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms.
• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Most of the companies cited were involved in the Food and Cosmetics 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
Catalina Finer Food, LLC	Food and Cosmetics	11/02/2023	Manufacturing, processing, packing, holding - Controls
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Records - equipment cleaning and sanitizing
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Treat seed with a scientifically valid method
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Sanitary food contact surfaces
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Environmental testing requirements
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Testing spent irrigation water
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Written environmental monitoring plan
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Written sampling plan for spent irrigation water or sprouts
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Release before negative test results
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	10/13/2023	Record - treatment
Ultrum Labs, LLC	Drugs	10/16/2023	Procedures not in writing, fully followed
Ultrum Labs, LLC	Drugs	10/16/2023	Written procedures not established/followed
Ultrum Labs, LLC	Drugs	10/16/2023	Computer control of master formula records
Ultrum Labs, LLC	Drugs	10/16/2023	Components withheld from use pending release
Ultrum Labs, LLC	Drugs	10/16/2023	Absence of Written Procedures
Ultrum Labs, LLC	Drugs	10/16/2023	SOPs not followed / documented