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Sunday, November 17, 2024

How many companies in cities across Queens County received FDA citations in February?

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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 were two companies in a city associated with Queens County that received FDA citations as a result of two inspections conducted in the county in February, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% decrease from the number of companies cited in the previous month.

The citations in the county include:

  • You did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
  • The eligibility of an HCT/P donor was not determined by a responsible person, based on results of donor screening and donor testing.
  • HCT/Ps for which the applicable donor eligibility requirements were not met were not prominently labeled with the appropriate warning statements.

Both companies cited should take voluntary actions to correct their 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 Queens County Cities and the citations they received in February
Company NameArea of BusinessInspection DateIssue Cited
Neurodynamics, Inc.Devices02/28/2024Lack of Written MDR Procedures
New Hope Fertility CenterBiologics02/22/2024Testing, screening, donor eligibility procedures
New Hope Fertility CenterBiologics02/22/2024Responsible person to determine, document
New Hope Fertility CenterBiologics02/22/2024Eligibility not required--warning labels

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