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Thursday, November 21, 2024

How many companies in cities across Orleans Parish received FDA citations in July?

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

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

This is an increase over the number of companies cited in the previous month.

The citations in the county were 'Biological product deviations were not reported within the 45 calendar day timeframe' and 'Written standard operating procedures including all steps to be followed in the collection, processing, compatibility testing, storage and distribution of blood and blood components for allogeneic transfusion were not always followed'.

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 Orleans Parish Cities and the citations they received in July
Company NameArea of BusinessInspection DateIssue Cited
Ochsner Health System Blood BankBiologics07/05/2024When to report
Ochsner Health System Blood BankBiologics07/05/2024Establish, maintain and follow manufacturing SOPs

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