Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is a 20% decrease from the number of companies cited in the previous year.
The citations in the county include:
- You did not develop an FSVP.
- You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.
- You did not establish written procedures to ensure that you import foods only from approved foreign suppliers.
All of the companies cited were involved in either Food and Cosmetics or Devices sectors.
Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).
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 |
|---|---|---|---|
| FoodForce Enterprise, Inc. | Food and Cosmetics | 06/07/2024 | Develop FSVP |
| FoodForce Enterprise, Inc. | Food and Cosmetics | 06/07/2024 | Supplier approval - document |
| FoodForce Enterprise, Inc. | Food and Cosmetics | 06/07/2024 | Approved supplier procedures - importer established |
| FoodForce Enterprise, Inc. | Food and Cosmetics | 06/07/2024 | Verification activity assurance |
| Ordont Orthodontic Laboratories, Inc. | Devices | 02/08/2024 | Label to bear a unique device identifier |
| Ordont Orthodontic Laboratories, Inc. | Devices | 02/08/2024 | Quality Audit/Reaudit - conducted |
| Ordont Orthodontic Laboratories, Inc. | Devices | 02/08/2024 | Training - Lack of or inadequate procedures |
| Ordont Orthodontic Laboratories, Inc. | Devices | 02/08/2024 | Design history file |
| Ordont Orthodontic Laboratories, Inc. | Devices | 02/08/2024 | Lack of or inadequate procedures |
| Ordont Orthodontic Laboratories, Inc. | Devices | 02/08/2024 | DHR - not or inadequately maintained |
| Ordont Orthodontic Laboratories, Inc. | Devices | 02/08/2024 | Complaints |
| Ordont Orthodontic Laboratories, Inc. | Devices | 02/08/2024 | Devices subject to device identification GUDID data submission requirements. |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Training content requirements |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Training for supervisors |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Ag. water - annual inspection |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Ag. water - E.coli standard |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Equip & tools - cleanability |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Buildings - prevent contamination |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Sanitary food contact surfaces |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Written environmental monitoring plan |
| St. Louis Calco, LLC | Food and Cosmetics | 09/10/2024 | Record requirements |
| Surgical Instrument Manufacturers, LLC | Devices | 02/22/2024 | Lack of or inadequate procedures |
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