James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 20% decrease from the number of companies cited in the previous quarter.
Of the 16 citations issued, the most common citation was 'Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination'.
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 |
|---|---|---|---|
| Baba Natural Foods, Inc. | Food and Cosmetics | 04/03/2024 | Sanitary operations - Plant sanitation |
| Baba Natural Foods, Inc. | Food and Cosmetics | 04/03/2024 | Sanitation of food-contact surfaces - Frequency |
| Baba Natural Foods, Inc. | Food and Cosmetics | 04/03/2024 | Equipment and utensils - Design and maintenance |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Hazard analysis written |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Hazard analysis biological, chemical, physical |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Document review entity's hazard analysis |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Evaluation - performance, risk |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Approved supplier procedures - importer established |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Unapproved supplier procedures - importer established |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Supplier verification - establish written procedures |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Verification activity assurance |
| Morano General Trading, Inc. | Food and Cosmetics | 05/29/2024 | Verification activity before import, periodically |
| Pathway, LLC | Devices | 05/22/2024 | Devices subject to device identification GUDID data submission requirements. |
| San Diego Coffee, Tea and Spice | Food and Cosmetics | 05/02/2024 | Sanitary operations - Plant sanitation |
| San Diego Coffee, Tea and Spice | Food and Cosmetics | 05/02/2024 | Pest control |
| San Diego Coffee, Tea and Spice | Food and Cosmetics | 05/02/2024 | Equipment and utensils - Design and maintenance |
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