Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 41.7% decrease from the number of companies cited in the previous year.
Of the 23 citations issued, the most common citation was 'Your hazard analysis did not identify a hazard that required a preventive control'.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).
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 |
|---|---|---|---|
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | Qualifications of individuals |
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | Hazard analysis - Conducted |
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | Hazard analysis - Identification of hazard |
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | Process preventive controls - Implement |
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | HACCP plan implementation |
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | Monitoring - adequacy |
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | Corrective action plan |
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | Verification procedures - adequacy |
| Avanti Foods Corporation | Food and Cosmetics | 06/25/2024 | Signed and dated |
| Companion Natural Pet Food, LLC | Veterinary | 04/29/2024 | Raw Material Controls |
| Companion Natural Pet Food, LLC | Veterinary | 04/29/2024 | Manufacturing, Processing, Packing, Holding - Measures |
| Grebe's Bakery, Inc. | Food and Cosmetics | 12/11/2024 | Plant construction and design |
| Grebe's Bakery, Inc. | Food and Cosmetics | 12/11/2024 | Hazard analysis - Identification of hazard |
| Indian Groceries and Spices, Inc. | Food and Cosmetics | 05/01/2024 | Hazard analysis written |
| Indian Groceries and Spices, Inc. | Food and Cosmetics | 05/01/2024 | Hazard analysis biological, chemical, physical |
| Indian Groceries and Spices, Inc. | Food and Cosmetics | 05/01/2024 | Verification activity assurance |
| Indian Groceries and Spices, Inc. | Food and Cosmetics | 05/01/2024 | Verification activity frequency |
| Indian Groceries and Spices, Inc. | Food and Cosmetics | 05/01/2024 | Verification activity - appropriate |
| Indian Groceries and Spices, Inc. | Food and Cosmetics | 05/01/2024 | Verification activity before import, periodically |
| Lynn Malec, M.D. | Biologics | 01/08/2024 | Case history records- inadequate or inadequate |
| Papas Bakery, Inc. | Food and Cosmetics | 06/18/2024 | Manufacturing, processing, packing, holding - Controls |
| Sant' Elia Operations, LLC | Food and Cosmetics | 08/07/2024 | Food safety plan |
| Sant' Elia Operations, LLC | Food and Cosmetics | 05/03/2024 | Develop FSVP |
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