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 27.3% decrease from the number of companies cited in the previous month.
Of the 24 citations issued, the most common citations include:
- You did not develop an FSVP.
- 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.
- An onsite audit of a foreign supplier did not consider an applicable food safety regulation.
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 |
|---|---|---|---|
| Adolfo Ponce | Food and Cosmetics | 03/14/2024 | Supplier approval - document |
| Adolfo Ponce | Food and Cosmetics | 03/14/2024 | Approved supplier procedures - importer established |
| Adolfo Ponce | Food and Cosmetics | 03/14/2024 | Record - translate to English |
| Cosmos Food Company, Inc. | Food and Cosmetics | 03/27/2024 | Allergen preventive controls - Implement |
| GMS International Foods, Inc. | Food and Cosmetics | 03/20/2024 | Pest control |
| Green Planet Traders, Inc. | Food and Cosmetics | 03/20/2024 | Develop FSVP |
| Green Planet Traders, Inc. | Food and Cosmetics | 03/20/2024 | Evaluation - performance, risk |
| Green Planet Traders, Inc. | Food and Cosmetics | 03/20/2024 | Audit - food safety regulation, plan |
| IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Personnel |
| IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Sanitary operations - Plant sanitation |
| IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Pest control |
| IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Sanitation of food-contact surfaces - Frequency |
| IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Equipment and utensils - Design and maintenance |
| IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Plant operations - Precautions |
| IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Storage and Distribution |
| JH corporation | Food and Cosmetics | 03/21/2024 | Develop FSVP |
| Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Procedures not in writing, fully followed |
| Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Cleaning / Sanitizing / Maintenance |
| Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Cleaning SOPs/instructions |
| Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Items to cover on annual reviews |
| Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Procedures to be written and followed |
| Seoul Trading, Inc. | Food and Cosmetics | 03/13/2024 | Hazard analysis biological, chemical, physical |
| Seoul Trading, Inc. | Food and Cosmetics | 03/13/2024 | Evaluation - performance, risk |
| Seoul Trading, Inc. | Food and Cosmetics | 03/13/2024 | Audit - food safety regulation, plan |
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