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Seattle City Wire

Monday, November 18, 2024

How many companies in cities across King County received FDA citations in Q2?

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

There were two companies in cities associated with King County that received FDA citations as a result of two inspections conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 60% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

  • Your hazard analysis did not identify a hazard that required a preventive control.
  • You did not implement your allergen monitoring procedures.
  • Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.

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 King County Cities and the citations they received in Q2
Company NameArea of BusinessInspection DateIssue Cited
Alki Bakery, Inc.Food and Cosmetics04/05/2024Hazard analysis - Identification of hazard
Alki Bakery, Inc.Food and Cosmetics04/05/2024Allergen preventive controls - Implement
BloodworksBiologics05/03/2024Component identity verification

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