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.
| 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 |



