Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is a 75% increase over the number of companies cited in the previous year.
The citations in the county include:
- Your plant did not have adequate sanitary facilities and accommodations.
- You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
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%).
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 |
|---|---|---|---|
| Apneicare, LLC | Devices | 04/12/2024 | Labeling requirements for stand-alone software |
| Apneicare, LLC | Devices | 04/12/2024 | Purchasing controls, Lack of or inadequate procedures |
| Apneicare, LLC | Devices | 04/12/2024 | Investigation of device failures |
| Auddinos Italian Bakery, Inc. | Food and Cosmetics | 08/22/2024 | Personnel |
| Auddinos Italian Bakery, Inc. | Food and Cosmetics | 08/22/2024 | Storage and Distribution |
| Bertec, Corp. | Devices | 02/12/2024 | Purchasing controls, Lack of or inadequate procedures |
| Entrotech Life Sciences, Inc. | Devices | 07/01/2024 | Quality audits - auditor independence |
| Entrotech Life Sciences, Inc. | Devices | 07/01/2024 | Lack of or inadequate procedures |
| Krispy Kreme Doughnut Corporation | Food and Cosmetics | 05/09/2024 | Sanitary facilities and controls |
| Krispy Kreme Doughnut Corporation | Food and Cosmetics | 05/09/2024 | Manufacturing, processing, packing, holding - Controls |
| Ocean Providence Columbus, LLC | Food and Cosmetics | 06/11/2024 | Food safety hazards |
| Sammy s Bagels, LLC | Food and Cosmetics | 11/18/2024 | Qualifications of individuals |
| Sammy s Bagels, LLC | Food and Cosmetics | 11/18/2024 | Plant construction and design |
| Sammy s Bagels, LLC | Food and Cosmetics | 11/18/2024 | Sanitary operations - Plant maintenance |
| Sammy s Bagels, LLC | Food and Cosmetics | 11/18/2024 | Cleaning and sanitizing substances - Safe and adequate |
| Sammy s Bagels, LLC | Food and Cosmetics | 11/18/2024 | Manufacturing, processing, packing, holding - Controls |
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