There were two companies in cities associated with Pinellas County that received FDA citations as a result of two inspections conducted in the county over the second quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not keep the grounds of your physical plant in a condition that protects against contamination of components, dietary supplements, or contact surfaces.
- Your hand-washing facilities are not adequate.
- You did not maintain, clean and sanitize equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements.
The companies cited were involved in either Food and Cosmetics or Drugs sectors.
Both 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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Formulated Solutions, LLC | Drugs | 04/04/2025 | Procedures not in writing, fully followed |
| Formulated Solutions, LLC | Drugs | 04/04/2025 | Cleaning / Sanitizing / Maintenance |
| 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 |
