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Marin Leader

Wednesday, November 6, 2024

How many companies in cities across Marin County received FDA citations in 2023?

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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 three companies in cities associated with Marin County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 25% decrease from the number of companies cited in the previous year.

The citations in the county include:

  • You did not document your review and assessment of a hazard analysis conducted by another entity.
  • You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
  • You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.

All of the companies cited were involved in the Food and Cosmetics sector.

All of the 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 Marin County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
California Caviar Company, LLCFood and Cosmetics08/24/2023HACCP plan implementation
California Caviar Company, LLCFood and Cosmetics08/24/2023Critical control points
California Caviar Company, LLCFood and Cosmetics08/24/2023Critical limits
California Caviar Company, LLCFood and Cosmetics08/24/2023Signed and dated
S H 1610, Inc.Food and Cosmetics05/30/2023Develop FSVP
Terrafresh Organics, LLCFood and Cosmetics09/01/2023Document review entity's hazard analysis
Terrafresh Organics, LLCFood and Cosmetics09/01/2023Evaluation - performance, risk
Terrafresh Organics, LLCFood and Cosmetics09/01/2023Supplier approval - document
Terrafresh Organics, LLCFood and Cosmetics09/01/2023Verification activity frequency
Terrafresh Organics, LLCFood and Cosmetics09/01/2023Verification activity review, assess

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