DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 12.5% increase over the number of companies cited in the previous quarter.
Of the 29 citations issued, the most common citation was 'You did not develop an FSVP'.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, nine should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (11.1%).
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 |
|---|---|---|---|
| A. B. Company, Inc. | Food and Cosmetics | 03/22/2024 | Develop FSVP |
| Chicago Housewares, Inc. | Food and Cosmetics | 02/26/2024 | Personnel |
| Chicago Housewares, Inc. | Food and Cosmetics | 02/26/2024 | Sanitary operations - Plant sanitation |
| Eco Food Distribution, LLC | Food and Cosmetics | 02/07/2024 | Develop FSVP |
| IKEA Food Supply, Inc. | Food and Cosmetics | 02/05/2024 | Develop FSVP |
| IKEA Food Supply, Inc. | Food and Cosmetics | 02/05/2024 | Identification - entry |
| IKEA Food Supply, Inc. | Veterinary | 02/05/2024 | Develop FSVP |
| IKEA Food Supply, Inc. | Veterinary | 02/05/2024 | Identification - entry |
| Keurig Dr Pepper | Food and Cosmetics | 02/01/2024 | Personnel |
| Keurig Dr Pepper | Food and Cosmetics | 02/01/2024 | Sanitary operations - Plant sanitation |
| Keurig Dr Pepper | Food and Cosmetics | 02/01/2024 | Pest control |
| Keurig Dr Pepper | Food and Cosmetics | 02/01/2024 | Sanitation of non-food-contact surfaces - Manner and frequency |
| Keurig Dr Pepper | Food and Cosmetics | 02/01/2024 | Appropriate quality control operations |
| Keurig Dr Pepper | Food and Cosmetics | 02/01/2024 | Other preventive controls - Implement |
| MEDLINE INDUSTRIES, LP - Northfield | Devices | 01/22/2024 | Individual Report of Malfunction |
| MEDLINE INDUSTRIES, LP - Northfield | Devices | 01/22/2024 | Design changes - Lack of or Inadequate Procedures |
| MEDLINE INDUSTRIES, LP - Northfield | Devices | 01/22/2024 | Purchasing controls, Lack of or inadequate procedures |
| MEDLINE INDUSTRIES, LP - Northfield | Devices | 01/22/2024 | Lack of or inadequate procedures |
| MEDLINE INDUSTRIES, LP - Northfield | Devices | 01/22/2024 | Lack of or inadequate complaint procedures |
| Mars Foods US | Food and Cosmetics | 01/11/2024 | Identification - entry |
| RNA Coporation | Drugs | 03/08/2024 | Procedures not in writing, fully followed |
| RNA Coporation | Drugs | 03/08/2024 | Buildings of Suitable Size, Construction, Location |
| RNA Coporation | Drugs | 03/08/2024 | Computer control of master formula records |
| RNA Coporation | Drugs | 03/08/2024 | Procedures for non-sterile drug products |
| VHRK Food, Inc. | Food and Cosmetics | 03/27/2024 | Hazard analysis biological, chemical, physical |
| VHRK Food, Inc. | Food and Cosmetics | 03/27/2024 | Document review entity's hazard analysis |
| VHRK Food, Inc. | Food and Cosmetics | 03/27/2024 | Approved supplier procedures - importer established |
| VHRK Food, Inc. | Food and Cosmetics | 03/27/2024 | Supplier verification - establish written procedures |
| VHRK Food, Inc. | Food and Cosmetics | 03/27/2024 | Verification activity assurance |
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