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 an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.
- You did not take adequate precautions to prevent contamination of animal food, use testing procedures to identify sanitation failures and conduct all animal food manufacturing under such conditions and controls to protect against contamination of animal food.
- You did not maintain animal food under conditions that will minimize the potential for growth of undesirable microorganisms during manufacturing, processing, packing, and holding.
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 |
---|---|---|---|
Mead Johnson & Company, LLC | Food and Cosmetics | 12/01/2023 | System of process controls to prevent adulteration |
Schoenborn Family Farms | Veterinary | 12/15/2023 | Plant Operations |
Schoenborn Family Farms | Veterinary | 12/15/2023 | Manufacturing, Processing, Packing, Holding Operations |