How many FDA citations were issued in cities within Pinellas County in 2025

Kyle Diamantas, J.D., Deputy Commissioner for Human Foods of FDA
Kyle Diamantas, J.D., Deputy Commissioner for Human Foods of FDA
0Comments

There were 19 companies in cities associated with Pinellas County that received FDA citations as a result of 19 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).

This is a 137.5% increase over the number of companies cited in the previous year.

Of the 83 citations issued, the most common citations include:

  • For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and limits on contamination to ensure the quality of the dietary supplement.
  • You did not establish product specifications for identity, purity, strength, composition and limits on contamination.
  • Your master manufacturing record did not include all required information.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Drugs 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.

According to its website, 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 and quality.

Companies Located within Pinellas County Cities and the Citations They Received in 2025
Company NameArea of BusinessInspection DateIssue Cited
BPI Labs, LLCDrugs04/23/2025Failure to comply with REMS Elements to Assure Safe Use (ETASU) A
Body, LLCFood and Cosmetics10/09/2025Specifications – components
Body, LLCFood and Cosmetics10/09/2025Specifications – finished dietary supplement
Body, LLCFood and Cosmetics10/09/2025Re-confirm certificate of analysis
Body, LLCFood and Cosmetics10/09/2025Reserve sample – collect, hold
Body, LLCFood and Cosmetics10/09/2025Quality control – processes, specifications, written procedures
Body, LLCFood and Cosmetics10/09/2025Master manufacturing record – prepared
Body, LLCFood and Cosmetics10/09/2025Master manufacturing record – record requirements
Body, LLCFood and Cosmetics10/09/2025Batch record – required information
Body, LLCFood and Cosmetics10/09/2025Written procedures – establish; returned dietary supplements
Cesarina Bakery, Inc.Food and Cosmetics07/16/2025Personnel
Cesarina Bakery, Inc.Food and Cosmetics07/16/2025Sanitary operations – Plant sanitation
Cesarina Bakery, Inc.Food and Cosmetics07/16/2025Raw materials – Allergen identification
Cesarina Bakery, Inc.Food and Cosmetics07/16/2025Process control – Foreign objects
Delicae Gourmet, LLCFood and Cosmetics07/30/2025Process filing
Delicae Gourmet, LLCFood and Cosmetics07/30/2025Appropriate quality control operations
Delicae Gourmet, LLCFood and Cosmetics07/30/2025Storage and Distribution
EyeKon Medical, Inc.Devices06/10/2025Supplier oversight
EyeKon Medical, Inc.Devices06/10/2025Calibration, Inspection, etc. Procedures Lack of or Inadequ
EyeKon Medical, Inc.Devices06/10/2025Lack of or inadequate procedures
EyeKon Medical, Inc.Devices06/10/2025Lack of or inadequate complaint procedures
Fishbusterz Madeira Bch, LLCFood and Cosmetics12/05/2025Verification – record review – frequency
Formulated Solutions, LLCDrugs04/04/2025Procedures not in writing, fully followed
Formulated Solutions, LLCDrugs04/04/2025Cleaning / Sanitizing / Maintenance
Frenchy’s Stone Crab, Inc.Food and Cosmetics10/28/2025Pest control
Frenchy’s Stone Crab, Inc.Food and Cosmetics10/28/2025Critical limits
Frenchy’s Stone Crab, Inc.Food and Cosmetics10/28/2025Corrective action plan
Frenchy’s Stone Crab, Inc.Food and Cosmetics10/28/2025Signed and dated
Frenchy’s Stone Crab, Inc.Food and Cosmetics10/28/2025Verification – record review – frequency
Health and Beauty Manufacturing, LLCFood and Cosmetics11/10/2025Make and keep records – equipment and utensils
Health and Beauty Manufacturing, LLCFood and Cosmetics11/10/2025Specifications – components
Health and Beauty Manufacturing, LLCFood and Cosmetics11/10/2025Specifications – finished dietary supplement
Health and Beauty Manufacturing, LLCFood and Cosmetics11/10/2025Master manufacturing record – record requirements
Health and Beauty Manufacturing, LLCFood and Cosmetics11/10/2025Batch record – required information
Marudhar, Inc.Food and Cosmetics08/28/2025No CGMPs – corrective action, procedures
Marudhar, Inc.Food and Cosmetics08/28/2025No CGMPs – investigate
Marudhar, Inc.Food and Cosmetics08/28/2025No CGMPs – reevaluate, factor
Marudhar, Inc.Food and Cosmetics08/28/2025No CGMPs – approval procedures
Marudhar, Inc.Food and Cosmetics08/28/2025No CGMPs – sampling, testing
Marudhar, Inc.Food and Cosmetics08/28/2025No CGMPs – food safety records
Mercury Enterprises, Inc.Devices12/11/2025Lack of or inadequate receiving acceptance procedures
Mercury Enterprises, Inc.Devices12/11/2025Lack of or inadequate procedures
Nulab, Inc.Food and Cosmetics05/14/2025Grounds – condition
Nulab, Inc.Food and Cosmetics05/14/2025Hand-washing facilities
Nulab, Inc.Food and Cosmetics05/14/2025Equipment – maintain – general
Nulab, Inc.Food and Cosmetics05/14/2025Equipment – automated – calibrate, inspect
Nulab, Inc.Food and Cosmetics05/14/2025Specifications – components
Nulab, Inc.Food and Cosmetics05/14/2025Specifications – finished dietary supplement
Nulab, Inc.Food and Cosmetics05/14/2025Component – verify identity, dietary ingredient
Nulab, Inc.Food and Cosmetics05/14/2025Appropriate tests, examinations; certificate of analysis
Nulab, Inc.Food and Cosmetics05/14/2025Quality control – Laboratory control processes; production, process control
Nulab, Inc.Food and Cosmetics05/14/2025Master manufacturing record – record requirements
Nulab, Inc.Food and Cosmetics05/14/2025Batch record – required information
Nulab, Inc.Food and Cosmetics05/14/2025Written procedures – follow; laboratory
Nulab, Inc.Food and Cosmetics05/14/2025Examination, testing; appropriate
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Specifications – components
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Specifications – finished dietary supplement
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Documentation specifications met; exempted, periodic testing
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Master manufacturing record – record requirements
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Batch record – required information
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Sampling plans; establish, follow
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Make and keep records – laboratory operations
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Processing lines, major equipment – contents
Nutraceuticals Factory, LLCFood and Cosmetics11/18/2025Product complaint – review, investigation
OneBlood, Inc.Biologics06/06/2025Biological product deviation report
Shire Nutraceuticals, LLCFood and Cosmetics08/29/2025Specifications – components
Shire Nutraceuticals, LLCFood and Cosmetics08/29/2025Specifications – finished dietary supplement
Shire Nutraceuticals, LLCFood and Cosmetics08/29/2025Documentation – specifications met; basis, quality control
Shire Nutraceuticals, LLCFood and Cosmetics08/29/2025Master manufacturing record – specifications, quality; packaging, labeling
Supplement Manufacturing Partner, Inc.Food and Cosmetics10/29/2025Specifications – finished dietary supplement
Supplement Manufacturing Partner, Inc.Food and Cosmetics10/29/2025Master manufacturing record – record requirements
Tejinder Glamour, M.D.Drugs06/17/2025FD-1572, protocol compliance
Tejinder Glamour, M.D.Drugs06/17/2025Case history records- inadequate or inadequate
Tejinder Glamour, M.D.Drugs06/17/2025Safety Reports – Serious Events
Viva 5, LLCFood and Cosmetics08/25/2025No CGMPs – establish procedures unapproved foreign supplier
Young Foundational Health Center, LLCFood and Cosmetics02/19/2025Written procedures – establish; quality control operations
Young Foundational Health Center, LLCFood and Cosmetics02/19/2025Written procedures – establish; components
Young Foundational Health Center, LLCFood and Cosmetics02/19/2025Master manufacturing record – prepared
Young Foundational Health Center, LLCFood and Cosmetics02/19/2025Batch record – every batch
Young Foundational Health Center, LLCFood and Cosmetics02/19/2025Written procedures – establish; packaging & labeling
Young Foundational Health Center, LLCFood and Cosmetics02/19/2025Written procedures – establish; holding and distribution
Young Foundational Health Center, LLCFood and Cosmetics02/19/2025Written procedures – establish; returned dietary supplements
Young Foundational Health Center, LLCFood and Cosmetics02/19/2025Written procedures – establish; product complaint
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



Related

Dr. Mehmet Oz CMS Administrator

Medicaid spending for state agency codes climbs 8.3% in Seminole in 2024

Medicaid payments linked to the National Codes Established for State Medicaid Agencies rose 8.3% in Seminole in 2024, indicating shifts in both service utilization and reimbursement trends.

U.S. Rep. Anna Paulina Luna representing Florida's 13th Congressional District

Rep. Luna introduces bill to restrict secret gender counseling in schools

Rep. Anna Paulina Luna has introduced legislation aimed at increasing parental involvement regarding student counseling on gender identity issues. The bill would restrict federal funding for schools that provide such counseling without parental knowledge.

Anna Paulina Luna, U.S. Representative from Florida's 13th Congressional District

Rep. Luna proposes legislation to tighten SNAP purchase rules for select foods

U.S. Rep. Anna Paulina Luna has put forward a bill in the U.S. House that seeks to limit the use of SNAP funds for foods lacking nutritional value.

Trending

The Weekly Newsletter

Sign-up for the Weekly Newsletter from South Pinellas Times.