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 month.
The citations in the county include:
- Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
- You did not establish an identity specification for each component.
- You did not establish component specifications for purity, strength and composition.
The company cited was involved in the Food and Cosmetics sector.
The company cited should take a voluntary action to correct its 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 |
---|---|---|---|
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Personnel - hygienic practices |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Specifications - component identity |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Specifications-component purity, strength, composition |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Specifications - contamination limits |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Specifications - identity, purity, strength, composition |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Tests, examinations - scientifically valid |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Master manufacturing record theoretical and expected yield |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Instructions; specifications; packaged, labeled |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Master manufacturing record - sampling, tests, examinations |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Batch record - initials; each step |
Country Life, LLC | Food and Cosmetics | 07/12/2024 | Hold - mix-up, contamination, deterioration |