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Akron Reporter

Saturday, September 28, 2024

FDA: 2 companies in cities within Summit County received 6 citations in Q1

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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 Summit County that received FDA citations as a result of two inspections 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 100% increase over the number of companies cited in the previous quarter.

The citations in the county include:

  • You did not have a written food safety plan.
  • Written MDR procedures have not been developed.
  • The type and extent of control to be exercised over the product, services and suppliers was not clearly defined.

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 Summit County Cities and the citations they received in Q1
Company NameArea of BusinessInspection DateIssue Cited
A & A Vending Company, Inc.Food and Cosmetics02/22/2024Food safety plan
Omega Laboratories, Inc.Devices02/08/2024Lack of Written MDR Procedures
Omega Laboratories, Inc.Devices02/08/2024Supplier oversight
Omega Laboratories, Inc.Devices02/08/2024Acceptable supplier records, inadequate records
Omega Laboratories, Inc.Devices02/08/2024Lack of or inadequate procedures
Omega Laboratories, Inc.Devices02/08/2024Lack of or inadequate complaint procedures

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