How many companies in cities across Santa Clara County received FDA citations in Q3?

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA - Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA - Official Website
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There were three companies in cities associated with Santa Clara County that received FDA citations as a result of three inspections conducted in the county over the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% increase over the number of companies cited in the previous quarter.

Of the 14 citations issued, the most common citations were ‘Personnel training is not documented’ and ‘Corrective and preventive action activities and/or results have not been adequately documented’.

Most of the companies cited were involved in the Devices 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 Santa Clara County Cities and the citations they received in Q3
Company Name Area of Business Inspection Date Issue Cited
Galli Produce Company, Inc. Food and Cosmetics 08/20/2024 Plant construction and design
Galli Produce Company, Inc. Food and Cosmetics 08/20/2024 Pest control
Galli Produce Company, Inc. Food and Cosmetics 08/20/2024 Supply-chain program – Assurance (Adequate)
Imedrix, Inc. Devices 07/24/2024 Records not kept
Imedrix, Inc. Devices 07/24/2024 Management review – defined interval, sufficient frequency
Imedrix, Inc. Devices 07/24/2024 Training records
Imedrix, Inc. Devices 07/24/2024 Design Validation – Risk analysis not performed/inadequate
Imedrix, Inc. Devices 07/24/2024 Procedures not adequately established or maintained
Imedrix, Inc. Devices 07/24/2024 Acceptable supplier records, inadequate records
Imedrix, Inc. Devices 07/24/2024 Documentation
Imedrix, Inc. Devices 07/24/2024 Complaints
North Coast Medical, Inc. Devices 08/02/2024 Training records
North Coast Medical, Inc. Devices 08/02/2024 Documentation
North Coast Medical, Inc. Devices 08/02/2024 Review and evaluation for investigation


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