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Thursday, October 31, 2024

FDA: 1 company in cities within Lincoln County received 2 citations in 2023

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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

There was one company in a city associated with Lincoln County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

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.

Companies Located Within Lincoln County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Cosette Pharmaceuticals NC Laboratories, LLCDrugs07/21/2023Incoming material area
Cosette Pharmaceuticals NC Laboratories, LLCDrugs07/21/2023Written Procedures Not Followed

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