FDA finds 3 violations during Feb. 3 inspection of Takari International in Ontario

Sean R. Keveney J.D., Chief Counsel of FDA
Sean R. Keveney J.D., Chief Counsel of FDA
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During its inspection on Feb. 3, the Food and Drug Administration (FDA) cited Takari International, Inc. in Ontario for three violations related to Foodborne Biological Hazards, as reported by the FDA’s website.

The website shows the following citations were issued to Takari International, Inc.:

  • ‘Your hazard analysis did not identify a hazard that requires a control.’
  • ‘You did not document that you reviewed and assessed an evaluation of a foreign supplier’s performance and the risk posed by a food that was performed by another entity.’
  • ‘For an onsite audit, you did not retain documentation of the dates the audit was conducted, of any corrective actions taken in response to significant deficiencies identified during the audit and that the audit was conducted by a qualified auditor.’

The FDA conducts regular inspections of facilities nationwide to assess compliance with laws and regulations designed to protect public health. Inspection outcomes are publicly posted.

As stated by the agency, the FDA oversees the production and distribution of human and animal drugs, biological products, medical supplies, and tobacco products to ensure their safety and quality.

Information for this article comes from the U.S. Food and Drug Administration. Source material is available here.



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