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 an increase over the number of companies cited in the previous month.
The citations in the county were 'Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met' and 'Your batch production records did not include the initials of the person responsible for adding a component to the batch'.
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 |
|---|---|---|---|
| Matsun Nutrition, Inc. | Food and Cosmetics | 07/09/2024 | Quality control production, process control; material review, disposition |
| Matsun Nutrition, Inc. | Food and Cosmetics | 07/09/2024 | Batch record - initials; component |
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