Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is a 150% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for design control have not been established.
- Documents were not available at all locations for which they are designated, used, or otherwise necessary.
- Records of acceptable contractors have not been adequately established.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, four should take voluntary actions to correct their managing operations (80%).
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 |
|---|---|---|---|
| Air Culinaire Worldwide, LLC | Food and Cosmetics | 09/11/2024 | Sanitation of food-contact surfaces - Frequency |
| Air Culinaire Worldwide, LLC | Food and Cosmetics | 09/11/2024 | Sanitation of non-food-contact surfaces - Manner and frequency |
| Air Culinaire Worldwide, LLC | Food and Cosmetics | 09/11/2024 | Manufacturing, processing, packing, holding - Controls |
| E&E Foods, Inc. | Food and Cosmetics | 07/29/2024 | Importer verification |
| LSG Sky Chefs, Inc. | Food and Cosmetics | 07/10/2024 | Manufacturing, processing, packing, holding - Controls |
| Personal Medical Corporation | Devices | 07/16/2024 | Design control - no procedures |
| Personal Medical Corporation | Devices | 07/16/2024 | Document locations, Dissemination, etc. |
| Personal Medical Corporation | Devices | 07/16/2024 | Acceptable supplier records, inadequate records |
| Personal Medical Corporation | Devices | 07/16/2024 | Lack of or inadequate procedures |
| R-Garden, LLC | Food and Cosmetics | 09/05/2024 | Written procedures - follow; quality control operations |
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