There were 10 companies in cities associated with San Mateo County that received FDA citations as a result of 11 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 16.7% decrease from the number of companies cited in the previous year.
The citations in the county include:
- You did not develop an FSVP.
- You did not have a written hazard analysis.
- You did not document your review and assessment of a hazard analysis conducted by another entity.
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 Drugs 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 |
|---|---|---|---|
| Bay Area Herbs & Specialties, LLC | Food and Cosmetics | 03/07/2024 | Grounds |
| Bay Area Herbs & Specialties, LLC | Food and Cosmetics | 03/07/2024 | Modified requirement: Temperature control – Implement |
| C and K Wholesale, LLC | Food and Cosmetics | 11/20/2024 | Equipment and utensils – Design and maintenance |
| C and K Wholesale, LLC | Food and Cosmetics | 11/20/2024 | HACCP plan implementation |
| C and K Wholesale, LLC | Food and Cosmetics | 11/20/2024 | Verification procedures – adequacy |
| C and K Wholesale, LLC | Food and Cosmetics | 11/20/2024 | Records values/observations |
| C and K Wholesale, LLC | Food and Cosmetics | 11/20/2024 | Sanitation monitoring |
| Carcione’s Fresh Produce Company, Inc. | Food and Cosmetics | 01/04/2024 | Storage and Distribution |
| Cheesequakes! | Food and Cosmetics | 04/10/2024 | Personnel |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Develop FSVP |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Hazard analysis written |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Document review entity’s hazard analysis |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Evaluation – performance, risk |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Approved supplier procedures – importer established |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Supplier verification – establish written procedures |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Verification activity assurance |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Verification activity before import, periodically |
| De Sol, Corp. | Food and Cosmetics | 08/15/2024 | Record – translate to English |
| Genentech, Inc. | Drugs | 03/12/2024 | General responsibilities of sponsors |
| Genentech, Inc. | Drugs | 03/12/2024 | IND safety report |
| Genentech, Inc. | Drugs | 03/12/2024 | Records of receipt, shipment, disposition |
| Genentech, Inc. | Drugs | 05/02/2024 | Failure to comply with REMS Implementation System |
| Gilead Sciences, Inc. | Drugs | 01/22/2024 | Late submission of 15-day report |
| Italfoods, Inc. | Food and Cosmetics | 12/06/2024 | LACF compliance |
| Italfoods, Inc. | Food and Cosmetics | 12/06/2024 | Hazard analysis biological, chemical, physical |
| Peninsula Seafood of San Bruno, Inc. | Food and Cosmetics | 10/16/2024 | Plant construction and design |
| Peninsula Seafood of San Bruno, Inc. | Food and Cosmetics | 10/16/2024 | HACCP plan implementation |
| Peninsula Seafood of San Bruno, Inc. | Food and Cosmetics | 10/16/2024 | Corrective action plan |
| Peninsula Seafood of San Bruno, Inc. | Food and Cosmetics | 10/16/2024 | Corrective action per predetermined plan |
| Verily LIfe Sciences, LLC | Devices | 08/30/2024 | Lack of or inadequate procedures |
