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North Lancaster News

Thursday, November 7, 2024

How many companies in cities across Lancaster County received FDA citations in Q1?

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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 Lancaster County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 66.7% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

  • Input to and output from the computer and records or data are not checked for accuracy.
  • The batch production and control records are deficient in that they do not include the identity of major equipment used.
  • Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.

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 Lancaster County Cities and the citations they received in Q1
Company NameArea of BusinessInspection DateIssue Cited
Corixa CorporationBiologics02/09/2024input/output verification
Corixa CorporationBiologics02/09/2024Identification of Equipment and Lines
Corixa CorporationBiologics02/09/2024Biological product deviation report

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