FDA: 6 companies in cities within Will County received 11 citations in 2023
There were six companies in cities associated with Will County that received FDA citations as a result of six inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 14.3% decrease from the number of companies cited in the previous year.
Of the 11 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.
Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the 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 |
|---|---|---|---|
| Bofas Company Limited | Food and Cosmetics | 12/28/2023 | Very small importer assurances, supplier |
| ISOVAC Products, LLC | Devices | 05/11/2023 | Purchasing controls, Lack of or inadequate procedures |
| ISOVAC Products, LLC | Devices | 05/11/2023 | Lack of or inadequate In-process acceptance procedures |
| ISOVAC Products, LLC | Devices | 05/11/2023 | Documentation |
| Inventus Power, Inc. | Devices | 03/28/2023 | Lack of or inadequate procedures |
| Inventus Power, Inc. | Devices | 03/28/2023 | Documentation |
| Randy Morris School, M.D. | Biologics | 06/14/2023 | Risk factors, clinical evidence |
| Sands Impex, Inc. | Food and Cosmetics | 06/26/2023 | Develop FSVP |
| Stericycle, Inc. | Devices | 12/21/2023 | Management review - defined interval, sufficient frequency |
| Stericycle, Inc. | Devices | 12/21/2023 | Quality audits - Lack of or inadequate procedures |
| Stericycle, Inc. | Devices | 12/21/2023 | Lack of or inadequate procedures |