There were three companies in cities associated with Seminole County that received FDA citations as a result of three inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 50% decrease from the number of companies cited in the previous year.
The citations in the county include:
- For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you did not conduct and document or obtain documentation of an onsite audit of the foreign supplier at least annually after importing the food into the United States.
- Procedures for training and identifying training needs have not been adequately established.
- Document control procedures have not been adequately established.
All of the companies cited were involved in either Food and Cosmetics, Devices, or Drugs sectors.
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 |
|---|---|---|---|
| Freshpro, Inc. | Food and Cosmetics | 07/18/2024 | Onsite audit |
| Sac, LLC | Devices | 08/27/2024 | Training – Lack of or inadequate procedures |
| Sac, LLC | Devices | 08/27/2024 | Procedures not adequately established or maintained |
| Sac, LLC | Devices | 08/27/2024 | Lack of or inadequate receiving acceptance procedures |
| Sac, LLC | Devices | 08/27/2024 | Nonconforming product, Lack of or inadequate procedures |
| Sac, LLC | Devices | 08/27/2024 | Lack of or inadequate procedures |
| Sac, LLC | Devices | 08/27/2024 | Lack of or inadequate complaint procedures |
| Sofie Company | Drugs | 01/22/2024 | Personnel not qualified |
| Sofie Company | Drugs | 01/22/2024 | Orderly handling, prevention of mix-ups, prevention of contamination |
| Sofie Company | Drugs | 01/22/2024 | Adequate controls (general) |



