James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- Corrective and preventive action activities and/or results have not been adequately documented.
- A device history record has not been adequately maintained.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Both 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 |
|---|---|---|---|
| Irish Acres, LLC | Veterinary | 05/11/2023 | ELDU - producer causes Illegal drug residue |
| Irish Acres, LLC | Veterinary | 05/11/2023 | Record keeping |
| Irish Acres, LLC | Veterinary | 05/11/2023 | Records review prior to shipment for slaughter |
| Wisconsin Aluminum Foundry Company, Inc. | Devices | 07/19/2023 | Documentation |
| Wisconsin Aluminum Foundry Company, Inc. | Devices | 07/19/2023 | DHR - not or inadequately maintained |
| Wisconsin Aluminum Foundry Company, Inc. | Devices | 07/19/2023 | Lack of or inadequate complaint procedures |
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