San Jose Standard

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.

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