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 fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- 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.
- Acceptance activities were not documented and maintained as part of the device history record.
- Procedures for corrective and preventive action have not been established.
The companies cited were involved in either Devices or Food and Cosmetics 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.
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, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| 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 |
| 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 |
