FDA issued 83 citations in cities across Pinellas County in 2025

Jim Traficant, Chief of Staff of FDA
Jim Traficant, Chief of Staff of FDA
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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 Name Area of Business Inspection Date Issue Cited
BPI Labs, LLC Drugs 04/23/2025 Failure to comply with REMS Elements to Assure Safe Use (ETASU) A
Body, LLC Food and Cosmetics 10/09/2025 Specifications – components
Body, LLC Food and Cosmetics 10/09/2025 Specifications – finished dietary supplement
Body, LLC Food and Cosmetics 10/09/2025 Re-confirm certificate of analysis
Body, LLC Food and Cosmetics 10/09/2025 Reserve sample – collect, hold
Body, LLC Food and Cosmetics 10/09/2025 Quality control – processes, specifications, written procedures
Body, LLC Food and Cosmetics 10/09/2025 Master manufacturing record – prepared
Body, LLC Food and Cosmetics 10/09/2025 Master manufacturing record – record requirements
Body, LLC Food and Cosmetics 10/09/2025 Batch record – required information
Body, LLC Food and Cosmetics 10/09/2025 Written procedures – establish; returned dietary supplements
Cesarina Bakery, Inc. Food and Cosmetics 07/16/2025 Personnel
Cesarina Bakery, Inc. Food and Cosmetics 07/16/2025 Sanitary operations – Plant sanitation
Cesarina Bakery, Inc. Food and Cosmetics 07/16/2025 Raw materials – Allergen identification
Cesarina Bakery, Inc. Food and Cosmetics 07/16/2025 Process control – Foreign objects
Delicae Gourmet, LLC Food and Cosmetics 07/30/2025 Process filing
Delicae Gourmet, LLC Food and Cosmetics 07/30/2025 Appropriate quality control operations
Delicae Gourmet, LLC Food and Cosmetics 07/30/2025 Storage and Distribution
EyeKon Medical, Inc. Devices 06/10/2025 Supplier oversight
EyeKon Medical, Inc. Devices 06/10/2025 Calibration, Inspection, etc. Procedures Lack of or Inadequ
EyeKon Medical, Inc. Devices 06/10/2025 Lack of or inadequate procedures
EyeKon Medical, Inc. Devices 06/10/2025 Lack of or inadequate complaint procedures
Fishbusterz Madeira Bch, LLC Food and Cosmetics 12/05/2025 Verification – record review – frequency
Formulated Solutions, LLC Drugs 04/04/2025 Procedures not in writing, fully followed
Formulated Solutions, LLC Drugs 04/04/2025 Cleaning / Sanitizing / Maintenance
Frenchy’s Stone Crab, Inc. Food and Cosmetics 10/28/2025 Pest control
Frenchy’s Stone Crab, Inc. Food and Cosmetics 10/28/2025 Critical limits
Frenchy’s Stone Crab, Inc. Food and Cosmetics 10/28/2025 Corrective action plan
Frenchy’s Stone Crab, Inc. Food and Cosmetics 10/28/2025 Signed and dated
Frenchy’s Stone Crab, Inc. Food and Cosmetics 10/28/2025 Verification – record review – frequency
Health and Beauty Manufacturing, LLC Food and Cosmetics 11/10/2025 Make and keep records – equipment and utensils
Health and Beauty Manufacturing, LLC Food and Cosmetics 11/10/2025 Specifications – components
Health and Beauty Manufacturing, LLC Food and Cosmetics 11/10/2025 Specifications – finished dietary supplement
Health and Beauty Manufacturing, LLC Food and Cosmetics 11/10/2025 Master manufacturing record – record requirements
Health and Beauty Manufacturing, LLC Food and Cosmetics 11/10/2025 Batch record – required information
Marudhar, Inc. Food and Cosmetics 08/28/2025 No CGMPs – corrective action, procedures
Marudhar, Inc. Food and Cosmetics 08/28/2025 No CGMPs – investigate
Marudhar, Inc. Food and Cosmetics 08/28/2025 No CGMPs – reevaluate, factor
Marudhar, Inc. Food and Cosmetics 08/28/2025 No CGMPs – approval procedures
Marudhar, Inc. Food and Cosmetics 08/28/2025 No CGMPs – sampling, testing
Marudhar, Inc. Food and Cosmetics 08/28/2025 No CGMPs – food safety records
Mercury Enterprises, Inc. Devices 12/11/2025 Lack of or inadequate receiving acceptance procedures
Mercury Enterprises, Inc. Devices 12/11/2025 Lack of or inadequate procedures
Nulab, Inc. Food and Cosmetics 05/14/2025 Grounds – condition
Nulab, Inc. Food and Cosmetics 05/14/2025 Hand-washing facilities
Nulab, Inc. Food and Cosmetics 05/14/2025 Equipment – maintain – general
Nulab, Inc. Food and Cosmetics 05/14/2025 Equipment – automated – calibrate, inspect
Nulab, Inc. Food and Cosmetics 05/14/2025 Specifications – components
Nulab, Inc. Food and Cosmetics 05/14/2025 Specifications – finished dietary supplement
Nulab, Inc. Food and Cosmetics 05/14/2025 Component – verify identity, dietary ingredient
Nulab, Inc. Food and Cosmetics 05/14/2025 Appropriate tests, examinations; certificate of analysis
Nulab, Inc. Food and Cosmetics 05/14/2025 Quality control – Laboratory control processes; production, process control
Nulab, Inc. Food and Cosmetics 05/14/2025 Master manufacturing record – record requirements
Nulab, Inc. Food and Cosmetics 05/14/2025 Batch record – required information
Nulab, Inc. Food and Cosmetics 05/14/2025 Written procedures – follow; laboratory
Nulab, Inc. Food and Cosmetics 05/14/2025 Examination, testing; appropriate
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Specifications – components
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Specifications – finished dietary supplement
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Documentation specifications met; exempted, periodic testing
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Master manufacturing record – record requirements
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Batch record – required information
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Sampling plans; establish, follow
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Make and keep records – laboratory operations
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Processing lines, major equipment – contents
Nutraceuticals Factory, LLC Food and Cosmetics 11/18/2025 Product complaint – review, investigation
OneBlood, Inc. Biologics 06/06/2025 Biological product deviation report
Shire Nutraceuticals, LLC Food and Cosmetics 08/29/2025 Specifications – components
Shire Nutraceuticals, LLC Food and Cosmetics 08/29/2025 Specifications – finished dietary supplement
Shire Nutraceuticals, LLC Food and Cosmetics 08/29/2025 Documentation – specifications met; basis, quality control
Shire Nutraceuticals, LLC Food and Cosmetics 08/29/2025 Master manufacturing record – specifications, quality; packaging, labeling
Supplement Manufacturing Partner, Inc. Food and Cosmetics 10/29/2025 Specifications – finished dietary supplement
Supplement Manufacturing Partner, Inc. Food and Cosmetics 10/29/2025 Master manufacturing record – record requirements
Tejinder Glamour, M.D. Drugs 06/17/2025 FD-1572, protocol compliance
Tejinder Glamour, M.D. Drugs 06/17/2025 Case history records- inadequate or inadequate
Tejinder Glamour, M.D. Drugs 06/17/2025 Safety Reports – Serious Events
Viva 5, LLC Food and Cosmetics 08/25/2025 No CGMPs – establish procedures unapproved foreign supplier
Young Foundational Health Center, LLC Food and Cosmetics 02/19/2025 Written procedures – establish; quality control operations
Young Foundational Health Center, LLC Food and Cosmetics 02/19/2025 Written procedures – establish; components
Young Foundational Health Center, LLC Food and Cosmetics 02/19/2025 Master manufacturing record – prepared
Young Foundational Health Center, LLC Food and Cosmetics 02/19/2025 Batch record – every batch
Young Foundational Health Center, LLC Food and Cosmetics 02/19/2025 Written procedures – establish; packaging & labeling
Young Foundational Health Center, LLC Food and Cosmetics 02/19/2025 Written procedures – establish; holding and distribution
Young Foundational Health Center, LLC Food and Cosmetics 02/19/2025 Written procedures – establish; returned dietary supplements
Young Foundational Health Center, LLC Food and Cosmetics 02/19/2025 Written 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.



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