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 unchanged from the number of companies cited in the previous year.
The citations in the county were 'Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components and drug product containers pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging' and 'Written procedures are not followed for the storage and handling of components'.
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 |
---|---|---|---|
Cosette Pharmaceuticals NC Laboratories, LLC | Drugs | 07/21/2023 | Incoming material area |
Cosette Pharmaceuticals NC Laboratories, LLC | Drugs | 07/21/2023 | Written Procedures Not Followed |