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.
| 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 |



