There were 38 companies in cities associated with Alameda County that received FDA citations as a result of 38 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 2.7% increase over the number of companies cited in the previous year.
Of the 112 citations issued, the most common citation was ‘Your hazard analysis did not identify a hazard that required a preventive control’.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Drugs sector.
Of the companies cited, 35 should take voluntary actions to correct their managing operations (92.1%). Additionally, four companies had to take regulatory and/or administrative actions (10.5%).
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 and quality.
Companies Located within Alameda County Cities and the Citations They Received in 2025
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Abbott Diabetes Care, Inc. | Devices | 10/23/2025 | Individual Report of Malfunction |
| Abbott Diabetes Care, Inc. | Devices | 10/23/2025 | Design transfer – Lack of or inadequate procedures |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Equipment – design – appropriate and suitable |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Instruments – calibration |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Specifications – components |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Specifications – finished dietary supplement |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Component – qualify supplier |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Re-confirm certificate of analysis |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Specifications met – verify; finished batch |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Tests, examinations – scientifically valid |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Quality control production, process control; material review, disposition |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Master manufacturing record – specifications, quality; packaging, labeling |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Master manufacturing record – controls, procedures |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Batch record – each step |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Sampling plans; establish, follow |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Examination, testing; scientifically valid |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Manufacturing operations – sanitation |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Written procedures – establish; returned dietary supplements |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | No AE report made (dietary supplement) |
| American Poly Sales Company, Inc. | Food and Cosmetics | 04/22/2025 | Pest control |
| Biogenex Laboratories, Inc. | Devices | 10/06/2025 | Label to bear a unique device identifier |
| Biogenex Laboratories, Inc. | Devices | 10/06/2025 | Individual Report of Malfunction |
| Biogenex Laboratories, Inc. | Devices | 10/06/2025 | Lack of or inadequate complaint procedures |
| Blue Marine, Inc. | Food and Cosmetics | 05/06/2025 | HACCP plan implementation |
| Blue Marine, Inc. | Food and Cosmetics | 05/06/2025 | Calibration – adequacy |
| Blue Marine, Inc. | Food and Cosmetics | 05/06/2025 | Verification – record review – frequency |
| Blue Marine, Inc. | Food and Cosmetics | 05/06/2025 | Verification – record review – calibration |
| Blue Marine, Inc. | Food and Cosmetics | 05/06/2025 | Sanitation monitoring |
| BlueStar Refreshment Services, LLC | Food and Cosmetics | 12/05/2025 | Sanitary operations – Plant maintenance |
| Bread SRSLY, PBC | Food and Cosmetics | 05/20/2025 | Process preventive controls – Appropriate (Adequate) |
| Bread SRSLY, PBC | Food and Cosmetics | 05/20/2025 | Sanitation preventive controls – Appropriate (Adequate) |
| Bread SRSLY, PBC | Food and Cosmetics | 05/20/2025 | Other Preventive Controls – Appropriate (Adequate) |
| C J United Food Corporation | Food and Cosmetics | 03/27/2025 | Develop FSVP |
| C J United Food Corporation | Food and Cosmetics | 03/27/2025 | Hazard analysis biological, chemical, physical |
| C J United Food Corporation | Food and Cosmetics | 03/27/2025 | Document review entity’s hazard analysis |
| C J United Food Corporation | Food and Cosmetics | 03/27/2025 | Evaluation – performance, risk |
| C J United Food Corporation | Food and Cosmetics | 03/27/2025 | Approved supplier procedures – importer established |
| C J United Food Corporation | Food and Cosmetics | 03/27/2025 | Record – translate to English |
| Caravan Foods II, Inc. | Food and Cosmetics | 11/06/2025 | Hazard analysis – Identification of hazard |
| Caravan Foods II, Inc. | Veterinary | 11/06/2025 | Hazard analysis – Identification of hazard |
| Children’s Hospital and Research Center at Oakland | Biologics | 03/20/2025 | Concurrent documentation |
| Children’s Hospital and Research Center at Oakland | Biologics | 03/20/2025 | Required records |
| Columbia Cosmetics Manufacturing, Inc. | Drugs | 04/14/2025 | Cleaning SOPs/instructions |
| Columbia Cosmetics Manufacturing, Inc. | Drugs | 04/14/2025 | Identity Testing of Each Component |
| Columbia Cosmetics Manufacturing, Inc. | Drugs | 04/14/2025 | Reports of Analysis (Components) |
| Columbia Cosmetics Manufacturing, Inc. | Drugs | 04/14/2025 | Control procedures to monitor and validate performance |
| Columbia Cosmetics Manufacturing, Inc. | Drugs | 04/14/2025 | Failing drug products not rejected |
| Columbia Cosmetics Manufacturing, Inc. | Drugs | 04/14/2025 | Investigations of discrepancies, failures |
| Core-Mark Distributors | Food and Cosmetics | 04/23/2025 | Monitoring – adequacy |
| Day-Lee Foods, Inc. | Food and Cosmetics | 06/27/2025 | HACCP plan implementation |
| Day-Lee Foods, Inc. | Food and Cosmetics | 06/27/2025 | Food safety hazards |
| Day-Lee Foods, Inc. | Food and Cosmetics | 06/27/2025 | Monitoring – adequacy |
| Day-Lee Foods, Inc. | Food and Cosmetics | 06/27/2025 | Corrective action plan |
| Day-Lee Foods, Inc. | Food and Cosmetics | 06/27/2025 | Verification procedures – adequacy |
| Day-Lee Foods, Inc. | Food and Cosmetics | 06/27/2025 | Sanitation monitoring |
| G & N Produce | Food and Cosmetics | 04/07/2025 | Storage and Distribution |
| Global Commodities Corporation | Food and Cosmetics | 07/02/2025 | Hazard analysis |
| Global Commodities Corporation | Food and Cosmetics | 07/02/2025 | No HACCP plan |
| Global Commodities Corporation | Food and Cosmetics | 07/02/2025 | Sanitation Records |
| Global Commodities Corporation | Food and Cosmetics | 07/02/2025 | Importer verification |
| Gold Bear Produce, Corporation | Food and Cosmetics | 05/13/2025 | Plant construction and design |
| Gold Bear Produce, Corporation | Food and Cosmetics | 05/13/2025 | Sanitary operations – Plant maintenance |
| Golden 8 Distributions Systems, Inc. | Food and Cosmetics | 01/28/2025 | Hazard analysis written |
| Golden 8 Distributions Systems, Inc. | Food and Cosmetics | 01/28/2025 | Disclosure – customer subject cGMP |
| Grifols Diagnostic Solutions, Inc. | Biologics | 10/31/2025 | Investigator statement (FDA 1572) |
| Grocery Outlet, Inc. | Food and Cosmetics | 06/17/2025 | Develop FSVP |
| Guru Distributors, Inc. | Food and Cosmetics | 12/19/2025 | Grounds |
| Guru Distributors, Inc. | Food and Cosmetics | 12/19/2025 | Pest control |
| Haig’s Delicacies, LLC | Food and Cosmetics | 06/12/2025 | Hazard analysis – Identification of hazard |
| Libby Laboratories, Inc. | Drugs | 03/14/2025 | Components withheld from use pending release |
| Libby Laboratories, Inc. | Drugs | 03/14/2025 | Microbiological testing |
| Living Tree Community Foods | Food and Cosmetics | 09/03/2025 | Sanitation of food-contact surfaces – Frequency |
| Living Tree Community Foods | Food and Cosmetics | 09/03/2025 | Process control – Foreign objects |
| Medical Instrument Development Laboratories, Inc. | Devices | 08/13/2025 | Design input – Lack of or inadequate procedures |
| Medical Instrument Development Laboratories, Inc. | Devices | 08/13/2025 | Product rework procedures, Lack of or inadequate procedures |
| Medical Instrument Development Laboratories, Inc. | Devices | 08/13/2025 | Lack of or inadequate procedures |
| Medical Instrument Development Laboratories, Inc. | Devices | 08/13/2025 | Lack of or inadequate complaint procedures |
| Meredith Dairy, Inc. | Food and Cosmetics | 04/01/2025 | Develop FSVP |
| Middle East Children’S Alliance | Food and Cosmetics | 04/04/2025 | Hazard analysis written |
| Middle East Children’S Alliance | Food and Cosmetics | 04/04/2025 | Evaluation – performance, risk |
| Middle East Children’S Alliance | Food and Cosmetics | 04/04/2025 | Approved supplier procedures – importer established |
| Middle East Children’S Alliance | Food and Cosmetics | 04/04/2025 | Verification activity assurance |
| Middle East Children’S Alliance | Food and Cosmetics | 04/04/2025 | Verification activity before import, periodically |
| Najafi Pharma, Inc. | Drugs | 07/09/2025 | Procedures not in writing, fully followed |
| Najafi Pharma, Inc. | Drugs | 07/09/2025 | Computer control of master formula records |
| Najafi Pharma, Inc. | Drugs | 07/09/2025 | Sampling and testing plans not followed |
| Ocean Queen USA, Inc. | Food and Cosmetics | 07/16/2025 | HACCP plan implementation |
| Ocean Queen USA, Inc. | Food and Cosmetics | 07/16/2025 | Critical control points |
| Ocean Queen USA, Inc. | Food and Cosmetics | 07/16/2025 | Calibration – adequacy |
| Ocean Queen USA, Inc. | Food and Cosmetics | 07/16/2025 | Sanitation monitoring |
| Revance Therapeutics, Inc. | Drugs | 02/27/2025 | Scientifically sound laboratory controls |
| S. S. C, Inc. | Food and Cosmetics | 04/18/2025 | Importer verification |
| Sandhu Products, Inc. | Food and Cosmetics | 02/07/2025 | Equipment – maintain – general |
| Sandhu Products, Inc. | Food and Cosmetics | 02/07/2025 | Appropriate tests, examinations; certificate of analysis |
| Sandhu Products, Inc. | Food and Cosmetics | 02/07/2025 | Quality control – reject; specification not met |
| Sandhu Products, Inc. | Food and Cosmetics | 02/07/2025 | Batch record – required information |
| Smart World, LLC | Drugs | 06/03/2025 | Procedures not in writing, fully followed |
| Smart World, LLC | Drugs | 06/03/2025 | Buildings not maintained in good state of repair |
| Sonic Manufacturing Technologies, Inc. | Devices | 03/07/2025 | Complaints |
| Sun Botanicals, Inc. | Food and Cosmetics | 02/07/2025 | Specifications – finished dietary supplement |
| Sun Botanicals, Inc. | Food and Cosmetics | 02/07/2025 | Specifications met identity, purity, strength, comp,; basis |
| Sun Deep, Inc. | Drugs | 07/11/2025 | Testing Each Component for Conformity with Specs |
| Sun Deep, Inc. | Drugs | 07/11/2025 | Scientifically sound laboratory controls |
| Sun Deep, Inc. | Drugs | 07/11/2025 | Investigations of discrepancies, failures |
| Sun Deep, Inc. | Drugs | 07/11/2025 | Complete test data included in records |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Hazard analysis written |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Document review entity’s hazard analysis |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Supplier approval – document |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Approved supplier procedures – importer established |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Supplier verification – establish written procedures |
| Veterans Affairs Palo Alto Health Care System | Biologics | 02/13/2025 | Equipment observed, standardized, calibrated |
| Vicolo Wholesale, LLC | Food and Cosmetics | 02/10/2025 | Hazard analysis – Identification of hazard |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
