There were six companies in cities associated with Pinellas County that received FDA citations as a result of six inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 62.5% decrease from the number of companies cited in the previous year.
The citations in the county include:
- You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training.
- Your hazard analysis did not identify a hazard that required a preventive control.
- The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
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.
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 |
|---|---|---|---|
| Ahvery Bakes, LLC | Food and Cosmetics | 08/16/2024 | Qualifications of individuals |
| Ahvery Bakes, LLC | Food and Cosmetics | 08/16/2024 | Hazard analysis – Identification of hazard |
| Bio Herbal USA | Food and Cosmetics | 03/22/2024 | Written procedure quality control operations material review |
| Bio Herbal USA | Food and Cosmetics | 03/22/2024 | Written procedures – holding; distributing |
| Bio Herbal USA | Food and Cosmetics | 03/22/2024 | Written procedures – returned dietary supplement |
| Bio Herbal USA | Food and Cosmetics | 03/22/2024 | Written procedures – product complaint |
| Eagle Labs, Inc. | Food and Cosmetics | 10/31/2024 | Specifications – components |
| Eagle Labs, Inc. | Food and Cosmetics | 10/31/2024 | Specifications – finished dietary supplement |
| Eagle Labs, Inc. | Food and Cosmetics | 10/31/2024 | Tests, examinations – scientifically valid |
| Eagle Labs, Inc. | Food and Cosmetics | 10/31/2024 | Batch record – required information |
| Kesin Pharma | Drugs | 01/19/2024 | Buildings of Suitable Size, Construction, Location |
| Kesin Pharma | Drugs | 01/19/2024 | Written procedures not established/followed |
| Kesin Pharma | Drugs | 01/19/2024 | Calibration/Inspection/Checking not done |
| Kesin Pharma | Drugs | 01/19/2024 | Component written specification |
| Kesin Pharma | Drugs | 01/19/2024 | Absence of Written Procedures |
| Kesin Pharma | Drugs | 01/19/2024 | Lack of written stability program |
| Pace Technician, Inc. | Devices | 11/15/2024 | Label to bear a unique device identifier |
| Pace Technician, Inc. | Devices | 11/15/2024 | Documentation |
| Pace Technician, Inc. | Devices | 11/15/2024 | Lack of or inadequate procedures |
| Sammy’s Seafood, Inc. | Food and Cosmetics | 06/26/2024 | Training records – General requirements |
| Sammy’s Seafood, Inc. | Food and Cosmetics | 06/26/2024 | Signed and dated |
