Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 50% increase over the number of companies cited in the previous year.
The citations in the county include:
- Your hazard analysis did not identify a hazard that requires a control.
- You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
- Your foreign supplier verification activities did not provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented.
All of the companies cited were involved in either Veterinary, Food and Cosmetics, or Devices sectors.
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 |
---|---|---|---|
American Distribution and Manufacturing Company, LLC | Veterinary | 05/30/2024 | Hazard analysis biological, chemical, physical |
American Distribution and Manufacturing Company, LLC | Veterinary | 05/30/2024 | Supplier verification - establish written procedures |
American Distribution and Manufacturing Company, LLC | Veterinary | 05/30/2024 | Supplier verification assurance |
Murata Vios, Inc. | Devices | 12/11/2024 | Design verification - Lack of or inadequate procedures |
Murata Vios, Inc. | Devices | 12/11/2024 | Design validation- Lack of or inadequate procedures |
Murata Vios, Inc. | Devices | 12/11/2024 | Lack of or inadequate procedures |
Northern Tier Bakery, LLC | Food and Cosmetics | 11/27/2024 | HACCP plan implementation |