Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 73.7% decrease from the number of companies cited in the previous quarter.
Of the 19 citations issued, the most common citation was 'You did not exclude pests from your food plant to protect against contamination of food'.
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.
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 |
|---|---|---|---|
| Deka Trading Corporation | Food and Cosmetics | 12/18/2024 | Plant construction and design |
| Deka Trading Corporation | Food and Cosmetics | 12/18/2024 | Pest control |
| Dharma Research, Inc. | Devices | 12/11/2024 | Design validation - documentation |
| Dharma Research, Inc. | Devices | 12/11/2024 | Documentation |
| Dharma Research, Inc. | Devices | 12/11/2024 | DHR content |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 12/16/2024 | Storage and Distribution |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 12/16/2024 | Sanitation monitoring |
| Gonzalez and Nietos, LLC | Food and Cosmetics | 12/16/2024 | Importer verification |
| Innovative Transfusion Medicine, Inc. | Biologics | 10/07/2024 | Establish, maintain and follow manufacturing SOPs |
| Innovative Transfusion Medicine, Inc. | Biologics | 10/07/2024 | Required records |
| Innovative Transfusion Medicine, Inc. | Biologics | 10/07/2024 | Review Records to ID Previous Donations [Collecting Estab] |
| Innovative Transfusion Medicine, Inc. | Biologics | 10/07/2024 | Review Records ID Previous Donations [Collecting Estab] |
| Latin Flavors Enterprises, Inc. | Food and Cosmetics | 12/18/2024 | Personnel |
| Latin Flavors Enterprises, Inc. | Food and Cosmetics | 12/18/2024 | Sanitary operations - Plant maintenance |
| Latin Flavors Enterprises, Inc. | Food and Cosmetics | 12/18/2024 | Pest control |
| Latin Flavors Enterprises, Inc. | Food and Cosmetics | 12/18/2024 | Sanitation of food-contact surfaces - Frequency |
| Latin Flavors Enterprises, Inc. | Food and Cosmetics | 12/18/2024 | Equipment and utensils - Design and maintenance |
| Latin Flavors Enterprises, Inc. | Food and Cosmetics | 12/18/2024 | Raw materials and rework controls - Filth and contamination |
| Latin Flavors Enterprises, Inc. | Food and Cosmetics | 12/18/2024 | Food safety plan |
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