East Hillsborough News

There were 13 companies in cities associated with Hillsborough County that received FDA citations as a result of 14 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 7.1% decrease from the number of companies cited in the previous year.

Of the 74 citations issued, the most common citation was 'You did not establish component specifications for purity, strength and composition'.

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
Always Fresh Farms, LLC	Food and Cosmetics	04/11/2023	Develop FSVP
Always Fresh Farms, LLC	Food and Cosmetics	04/11/2023	Evaluation - performance, risk
Always Fresh Farms, LLC	Food and Cosmetics	04/11/2023	Audit - food safety regulation, plan
BayCare Integrated Service Center, LLC	Drugs	06/02/2023	Drug product labels, fails to include
Catalina Finer Food, LLC	Food and Cosmetics	11/02/2023	Manufacturing, processing, packing, holding - Controls
Flayco Products, Inc.	Food and Cosmetics	09/29/2023	Manufacturing, processing, packing, holding - Controls
Flayco Products, Inc.	Food and Cosmetics	09/29/2023	Hazard analysis - Conducted
Flayco Products, Inc.	Food and Cosmetics	09/29/2023	Sanitation preventive controls - Appropriate (Adequate)
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Outer garments
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Written procedures - cleaning
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Physical plant - size, construction, design
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Floors, walls, ceilings
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Specifications - component identity
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Specifications-component purity, strength, composition
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Specifications - identity, purity, strength, composition
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Master manufacturing record - unique formulation
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Specific actions; packaged, labeled
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Batch record - complete
Globo Pharma, Inc.	Food and Cosmetics	07/28/2023	Manufacturing operations - written procedures
KeyView Labs, Inc.	Food and Cosmetics	07/18/2023	Specifications-component purity, strength, composition
KeyView Labs, Inc.	Food and Cosmetics	07/18/2023	Component - certificate of analysis
KeyView Labs, Inc.	Food and Cosmetics	07/18/2023	Documentation - qualify supplier
Lonza Tampa, LLC	Drugs	09/29/2023	Procedures not in writing, fully followed
More Bakery, Inc.	Food and Cosmetics	05/26/2023	Personnel
More Bakery, Inc.	Food and Cosmetics	05/26/2023	Sanitary operations - Plant maintenance
More Bakery, Inc.	Food and Cosmetics	05/26/2023	Pest control
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Personnel - records - training
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Floors, walls, ceilings
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Physical plant - bulbs, fixtures, skylights
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Specifications-component purity, strength, composition
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Specifications - identity, purity, strength, composition
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Documentation - quality control, review, approve supplier
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Components - quarantine
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Master manufacturing record - each batch
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Batch record - date, time; maintenance
Pure Solutions, Inc.	Food and Cosmetics	04/13/2023	Written procedures - returned dietary supplement
Pure Solutions, Inc.	Veterinary	04/13/2023	Personnel - records - training
Pure Solutions, Inc.	Veterinary	04/13/2023	Floors, walls, ceilings
Pure Solutions, Inc.	Veterinary	04/13/2023	Physical plant - bulbs, fixtures, skylights
Pure Solutions, Inc.	Veterinary	04/13/2023	Specifications-component purity, strength, composition
Pure Solutions, Inc.	Veterinary	04/13/2023	Specifications - identity, purity, strength, composition
Pure Solutions, Inc.	Veterinary	04/13/2023	Documentation - quality control, review, approve supplier
Pure Solutions, Inc.	Veterinary	04/13/2023	Components - quarantine
Pure Solutions, Inc.	Veterinary	04/13/2023	Master manufacturing record - each batch
Pure Solutions, Inc.	Veterinary	04/13/2023	Batch record - date, time; maintenance
Pure Solutions, Inc.	Veterinary	04/13/2023	Written procedures - returned dietary supplement
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
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	03/30/2023	Non-food-contact surface maintenance and cleaning
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	03/30/2023	Treat seed with a scientifically valid method
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	03/30/2023	Sanitary food contact surfaces
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	03/30/2023	Environmental testing requirements
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	03/30/2023	Testing spent irrigation water
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	03/30/2023	Written environmental monitoring plan
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	03/30/2023	Written sampling plan for spent irrigation water or sprouts
Shun Shing Bean Sprouts, Inc.	Food and Cosmetics	03/30/2023	Release before negative test results
The Hay Exchange, Inc.	Veterinary	09/19/2023	Develop FSVP
Toufayan Bakery of Plant City	Food and Cosmetics	09/21/2023	Hazard analysis - Identification of hazard
Toufayan Bakery of Plant City	Food and Cosmetics	09/21/2023	Hazard Analysis
Toufayan Bakery of Plant City	Veterinary	09/21/2023	Hazard analysis - Identification of hazard
Toufayan Bakery of Plant City	Veterinary	09/21/2023	Hazard Analysis
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