There were three companies in cities associated with Hartford County that received FDA citations as a result of three inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 50% increase over the number of companies cited in the previous year.
The citations in the county include:
- Procedures for quality audits have not been adequately established.
- Procedures for training and identifying training needs have not been adequately established.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
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.
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 |
|---|---|---|---|
| EZ Noble Sushi | Food and Cosmetics | 03/29/2024 | HACCP plan implementation |
| Kelyniam Global, Inc. | Devices | 08/23/2024 | Quality audits – Lack of or inadequate procedures |
| Kelyniam Global, Inc. | Devices | 08/23/2024 | Training – Lack of or inadequate procedures |
| Kelyniam Global, Inc. | Devices | 08/23/2024 | Purchasing controls, Lack of or inadequate procedures |
| Kelyniam Global, Inc. | Devices | 08/23/2024 | Lack of or inadequate process validation |
| Kelyniam Global, Inc. | Devices | 08/23/2024 | DHR – not or inadequately maintained |
| Sardilli Produce & Dairy Company, Inc. | Food and Cosmetics | 04/18/2024 | Sanitary operations – Plant sanitation |
| Sardilli Produce & Dairy Company, Inc. | Food and Cosmetics | 04/18/2024 | Manufacturing, processing, packing, holding – Controls |
