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Holland Reporter

Thursday, November 7, 2024

Companies across Ottawa County cities saw 3 FDA citations in Q4 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

There were two companies in cities associated with Ottawa County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 2023, 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 quarter.

The citations in the county include:

  • You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.
  • You did not take adequate precautions to prevent contamination of animal food, use testing procedures to identify sanitation failures and conduct all animal food manufacturing under such conditions and controls to protect against contamination of animal food.
  • You did not maintain animal food under conditions that will minimize the potential for growth of undesirable microorganisms during manufacturing, processing, packing, and holding.

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 Ottawa County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Mead Johnson & Company, LLCFood and Cosmetics12/01/2023System of process controls to prevent adulteration
Schoenborn Family FarmsVeterinary12/15/2023Plant Operations
Schoenborn Family FarmsVeterinary12/15/2023Manufacturing, Processing, Packing, Holding Operations

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