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Saturday, December 21, 2024

How many FDA citations were issued in cities within Harris County in August

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

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

This is unchanged from the number of companies cited in the previous month.

The citations in the county were 'Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures' and 'Records do not include the disposition of rejected components, drug product containers and closures'.

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 Harris County Cities and the citations they received in August
Company NameArea of BusinessInspection DateIssue Cited
Airgas USA, LLCDrugs08/15/2024Records reviewed annually
Airgas USA, LLCDrugs08/15/2024Records of disposition of rejected material

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