Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- Your hazard analysis did not identify a hazard that requires a control.
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
- You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
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 |
|---|---|---|---|
| Elite Spice, Inc. | Food and Cosmetics | 01/25/2024 | Hazard analysis - Identification of hazard |
| Eni District, Inc. | Food and Cosmetics | 09/26/2024 | Hazard analysis biological, chemical, physical |
| Eni District, Inc. | Food and Cosmetics | 09/26/2024 | Evaluation - performance, risk |
| Eni District, Inc. | Food and Cosmetics | 09/26/2024 | Supplier verification - establish written procedures |
| Eni District, Inc. | Food and Cosmetics | 09/26/2024 | Verification activity frequency |
| Eni District, Inc. | Food and Cosmetics | 09/26/2024 | Verification activity before import, periodically |
| Gold Coast United, Inc. | Food and Cosmetics | 05/01/2024 | Personnel |
| Gold Coast United, Inc. | Food and Cosmetics | 05/01/2024 | Sanitary operations - Plant maintenance |
| Gold Coast United, Inc. | Food and Cosmetics | 05/01/2024 | Cleaning and sanitizing substances - Safe and adequate |
| Gold Coast United, Inc. | Food and Cosmetics | 05/01/2024 | Equipment and utensils - Design and maintenance |
| Samsung Bean Sprout | Food and Cosmetics | 06/04/2024 | Equipment installation, maintenance |
| Samsung Bean Sprout | Food and Cosmetics | 06/04/2024 | Documentation of corrective actions taken |
| Supreme Orthopedic Systems, Inc. | Biologics | 08/23/2024 | Capable of valid results |
| Supreme Orthopedic Systems, Inc. | Biologics | 08/23/2024 | Calibration procedures and schedules (general) |
| Supreme Orthopedic Systems, Inc. | Biologics | 08/23/2024 | Periodic review of temperatures |
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