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Wednesday, November 6, 2024

How many companies in cities across Hillsborough County received FDA citations in 2023?

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

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.

Companies Located Within Hillsborough County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Always Fresh Farms, LLCFood and Cosmetics04/11/2023Develop FSVP
Always Fresh Farms, LLCFood and Cosmetics04/11/2023Evaluation - performance, risk
Always Fresh Farms, LLCFood and Cosmetics04/11/2023Audit - food safety regulation, plan
BayCare Integrated Service Center, LLCDrugs06/02/2023Drug product labels, fails to include
Catalina Finer Food, LLCFood and Cosmetics11/02/2023Manufacturing, processing, packing, holding - Controls
Flayco Products, Inc.Food and Cosmetics09/29/2023Manufacturing, processing, packing, holding - Controls
Flayco Products, Inc.Food and Cosmetics09/29/2023Hazard analysis - Conducted
Flayco Products, Inc.Food and Cosmetics09/29/2023Sanitation preventive controls - Appropriate (Adequate)
Globo Pharma, Inc.Food and Cosmetics07/28/2023Outer garments
Globo Pharma, Inc.Food and Cosmetics07/28/2023Written procedures - cleaning
Globo Pharma, Inc.Food and Cosmetics07/28/2023Physical plant - size, construction, design
Globo Pharma, Inc.Food and Cosmetics07/28/2023Floors, walls, ceilings
Globo Pharma, Inc.Food and Cosmetics07/28/2023Specifications - component identity
Globo Pharma, Inc.Food and Cosmetics07/28/2023Specifications-component purity, strength, composition
Globo Pharma, Inc.Food and Cosmetics07/28/2023Specifications - identity, purity, strength, composition
Globo Pharma, Inc.Food and Cosmetics07/28/2023Master manufacturing record - unique formulation
Globo Pharma, Inc.Food and Cosmetics07/28/2023Specific actions; packaged, labeled
Globo Pharma, Inc.Food and Cosmetics07/28/2023Batch record - complete
Globo Pharma, Inc.Food and Cosmetics07/28/2023Manufacturing operations - written procedures
KeyView Labs, Inc.Food and Cosmetics07/18/2023Specifications-component purity, strength, composition
KeyView Labs, Inc.Food and Cosmetics07/18/2023Component - certificate of analysis
KeyView Labs, Inc.Food and Cosmetics07/18/2023Documentation - qualify supplier
Lonza Tampa, LLCDrugs09/29/2023Procedures not in writing, fully followed
More Bakery, Inc.Food and Cosmetics05/26/2023Personnel
More Bakery, Inc.Food and Cosmetics05/26/2023Sanitary operations - Plant maintenance
More Bakery, Inc.Food and Cosmetics05/26/2023Pest control
Pure Solutions, Inc.Food and Cosmetics04/13/2023Personnel - records - training
Pure Solutions, Inc.Food and Cosmetics04/13/2023Floors, walls, ceilings
Pure Solutions, Inc.Food and Cosmetics04/13/2023Physical plant - bulbs, fixtures, skylights
Pure Solutions, Inc.Food and Cosmetics04/13/2023Specifications-component purity, strength, composition
Pure Solutions, Inc.Food and Cosmetics04/13/2023Specifications - identity, purity, strength, composition
Pure Solutions, Inc.Food and Cosmetics04/13/2023Documentation - quality control, review, approve supplier
Pure Solutions, Inc.Food and Cosmetics04/13/2023Components - quarantine
Pure Solutions, Inc.Food and Cosmetics04/13/2023Master manufacturing record - each batch
Pure Solutions, Inc.Food and Cosmetics04/13/2023Batch record - date, time; maintenance
Pure Solutions, Inc.Food and Cosmetics04/13/2023Written procedures - returned dietary supplement
Pure Solutions, Inc.Veterinary04/13/2023Personnel - records - training
Pure Solutions, Inc.Veterinary04/13/2023Floors, walls, ceilings
Pure Solutions, Inc.Veterinary04/13/2023Physical plant - bulbs, fixtures, skylights
Pure Solutions, Inc.Veterinary04/13/2023Specifications-component purity, strength, composition
Pure Solutions, Inc.Veterinary04/13/2023Specifications - identity, purity, strength, composition
Pure Solutions, Inc.Veterinary04/13/2023Documentation - quality control, review, approve supplier
Pure Solutions, Inc.Veterinary04/13/2023Components - quarantine
Pure Solutions, Inc.Veterinary04/13/2023Master manufacturing record - each batch
Pure Solutions, Inc.Veterinary04/13/2023Batch record - date, time; maintenance
Pure Solutions, Inc.Veterinary04/13/2023Written procedures - returned dietary supplement
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Records - equipment cleaning and sanitizing
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Treat seed with a scientifically valid method
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Sanitary food contact surfaces
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Environmental testing requirements
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Testing spent irrigation water
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Written environmental monitoring plan
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Written sampling plan for spent irrigation water or sprouts
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Release before negative test results
Shun Shing Bean Sprouts, Inc.Food and Cosmetics10/13/2023Record - treatment
Shun Shing Bean Sprouts, Inc.Food and Cosmetics03/30/2023Non-food-contact surface maintenance and cleaning
Shun Shing Bean Sprouts, Inc.Food and Cosmetics03/30/2023Treat seed with a scientifically valid method
Shun Shing Bean Sprouts, Inc.Food and Cosmetics03/30/2023Sanitary food contact surfaces
Shun Shing Bean Sprouts, Inc.Food and Cosmetics03/30/2023Environmental testing requirements
Shun Shing Bean Sprouts, Inc.Food and Cosmetics03/30/2023Testing spent irrigation water
Shun Shing Bean Sprouts, Inc.Food and Cosmetics03/30/2023Written environmental monitoring plan
Shun Shing Bean Sprouts, Inc.Food and Cosmetics03/30/2023Written sampling plan for spent irrigation water or sprouts
Shun Shing Bean Sprouts, Inc.Food and Cosmetics03/30/2023Release before negative test results
The Hay Exchange, Inc.Veterinary09/19/2023Develop FSVP
Toufayan Bakery of Plant CityFood and Cosmetics09/21/2023Hazard analysis - Identification of hazard
Toufayan Bakery of Plant CityFood and Cosmetics09/21/2023Hazard Analysis
Toufayan Bakery of Plant CityVeterinary09/21/2023Hazard analysis - Identification of hazard
Toufayan Bakery of Plant CityVeterinary09/21/2023Hazard Analysis
Ultrum Labs, LLCDrugs10/16/2023Procedures not in writing, fully followed
Ultrum Labs, LLCDrugs10/16/2023Written procedures not established/followed
Ultrum Labs, LLCDrugs10/16/2023Computer control of master formula records
Ultrum Labs, LLCDrugs10/16/2023Components withheld from use pending release
Ultrum Labs, LLCDrugs10/16/2023Absence of Written Procedures
Ultrum Labs, LLCDrugs10/16/2023SOPs not followed / documented

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