FDA: 12 companies in cities within Santa Clara County received 43 citations in 2024

FDA: 12 companies in cities within Santa Clara County received 43 citations in 2024
Mark Raza Principal Deputy Chief Counsel - FDA — Official Website
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There were 12 companies in cities associated with Santa Clara County that received FDA citations as a result of 12 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 53.8% decrease from the number of companies cited in the previous year.

Of the 43 citations issued, the most common citations include:

  • Personnel training is not documented.
  • Corrective and preventive action activities and/or results have not been adequately documented.
  • You did not develop an FSVP.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked 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.

According to its website, 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.

Companies Located Within Santa Clara County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
Algomedica, Inc. Devices 03/28/2024 Management representative
Algomedica, Inc. Devices 03/28/2024 Management review – defined interval, sufficient frequency
Algomedica, Inc. Devices 03/28/2024 Quality Audits – defined intervals
Ande Foods, Inc. Food and Cosmetics 06/28/2024 Hazard analysis written
Ande Foods, Inc. Food and Cosmetics 06/28/2024 Evaluation – performance, risk
Ande Foods, Inc. Food and Cosmetics 06/28/2024 Approved supplier procedures – importer established
Ande Foods, Inc. Food and Cosmetics 06/28/2024 Supplier verification – establish written procedures
Ande Foods, Inc. Food and Cosmetics 06/28/2024 Verification activity assurance
Asap Sons Group, Inc. Food and Cosmetics 04/09/2024 Develop FSVP
Asap Sons Group, Inc. Food and Cosmetics 04/09/2024 Hazard analysis biological, chemical, physical
Asap Sons Group, Inc. Food and Cosmetics 04/09/2024 Document review entity’s hazard analysis
Asap Sons Group, Inc. Food and Cosmetics 04/09/2024 Evaluation – performance, risk
Asap Sons Group, Inc. Food and Cosmetics 04/09/2024 Approved supplier procedures – importer established
Asap Sons Group, Inc. Food and Cosmetics 04/09/2024 Verification activity before import, periodically
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)
IL Pastaio Food and Cosmetics 02/28/2024 Hazard analysis – Identification of hazard
IL Pastaio Food and Cosmetics 02/28/2024 No HACCP plan
IL Pastaio Food and Cosmetics 02/28/2024 Sanitation monitoring
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
New India Bazar, Inc. Food and Cosmetics 09/23/2024 Develop FSVP
New India Bazar, Inc. Food and Cosmetics 09/23/2024 Hazard analysis biological, chemical, physical
New India Bazar, Inc. Food and Cosmetics 09/23/2024 Evaluation – performance, risk
New India Bazar, Inc. Food and Cosmetics 09/23/2024 Verification activity before import, periodically
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
Qostronics Devices 05/23/2024 Sampling plans
Sally Arai, M.D. Drugs 03/06/2024 Consent form not approved/signed/dated
Stanford Blood Center Biologics 11/26/2024 input/output verification
Stanford Blood Center Biologics 11/26/2024 SOPs not followed / documented
Stanford Blood Center Biologics 11/26/2024 SOPs for investigations, records
Stanford Blood Center Biologics 11/26/2024 Schedules and procedures for equipment & calibration
Validation Systems, Inc. Drugs 09/05/2024 Procedures not in writing, fully followed
Validation Systems, Inc. Drugs 09/05/2024 Cleaning System


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