There were 61 companies in cities associated with San Diego County that received FDA citations as a result of 61 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 3.2% decrease from the number of companies cited in the previous year.
Of the 173 citations issued, the most common citation was ‘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 operated in the Devices sector.
Of the companies cited, 58 should take voluntary actions to correct their managing operations (95.1%). Additionally, two companies had to take regulatory and/or administrative actions (3.3%).
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 San Diego County Cities and the Citations They Received in 2025
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| ATOB Trade Company, Inc. | Food and Cosmetics | 02/12/2025 | Document review entity’s hazard analysis |
| ATOB Trade Company, Inc. | Food and Cosmetics | 02/12/2025 | Evaluation – performance, risk |
| Acai Roots, Inc. | Food and Cosmetics | 07/14/2025 | Hazard analysis biological, chemical, physical |
| Acai Roots, Inc. | Food and Cosmetics | 07/14/2025 | Evaluation – performance, risk |
| Acai Roots, Inc. | Food and Cosmetics | 07/14/2025 | Approved supplier procedures – importer established |
| Acai Roots, Inc. | Food and Cosmetics | 07/14/2025 | Supplier verification – establish written procedures |
| Activbody, Inc. | Devices | 08/22/2025 | Management review – Lack of or inadequate procedures |
| Activbody, Inc. | Devices | 08/22/2025 | Training – Lack of or inadequate procedures |
| Activbody, Inc. | Devices | 08/22/2025 | Design validation- Lack of or inadequate procedures |
| Activbody, Inc. | Devices | 08/22/2025 | Lack of or inadequate complaint procedures |
| Activbody, Inc. | Devices | 08/22/2025 | GUDID Information required for unique device identification. |
| Advin Biotech, Inc. | Devices | 09/05/2025 | Use and removal, Lack of or inadequate procedures |
| Air Culinaire Worldwide | Food and Cosmetics | 02/06/2025 | Food safety plan |
| Axia Medical Solutions, LLC | Drugs | 07/17/2025 | Procedures not in writing, fully followed |
| Axia Medical Solutions, LLC | Drugs | 07/17/2025 | Storage under appropriate conditions |
| Beloteca, Inc. | Drugs | 08/29/2025 | Failure to develop written procedures |
| Beloteca, Inc. | Drugs | 08/29/2025 | Late submission of annual safety reports |
| Beloteca, Inc. | Drugs | 08/29/2025 | Timely submission |
| CA BOTANA International, Inc. | Drugs | 04/04/2025 | Procedures not in writing, fully followed |
| CA BOTANA International, Inc. | Drugs | 04/04/2025 | Equipment Design, Size and Location |
| CA BOTANA International, Inc. | Drugs | 04/04/2025 | Component identity verification |
| CA BOTANA International, Inc. | Drugs | 04/04/2025 | Scientifically sound laboratory controls |
| CA BOTANA International, Inc. | Drugs | 04/04/2025 | Failing drug products not rejected |
| CGX, LLC | Devices | 04/03/2025 | Label to bear a unique device identifier |
| CGX, LLC | Devices | 04/03/2025 | Quality Audit/Reaudit – conducted |
| CGX, LLC | Devices | 04/03/2025 | Acceptable supplier records, inadequate records |
| CGX, LLC | Devices | 04/03/2025 | Lack of or inadequate complaint procedures |
| Cafe Moto, Inc. | Food and Cosmetics | 08/15/2025 | Personnel |
| Catalina Offshore Products, Inc. | Food and Cosmetics | 07/21/2025 | Sanitation monitoring |
| Cazares Del Golfo Produce | Food and Cosmetics | 11/04/2025 | Develop FSVP |
| Crawford, Daniel | Food and Cosmetics | 09/09/2025 | Develop FSVP |
| Diamond Jack Enterprises, Inc. | Food and Cosmetics | 09/24/2025 | Not registered |
| Diamond Jack Enterprises, Inc. | Food and Cosmetics | 09/24/2025 | Personnel |
| Diamond Jack Enterprises, Inc. | Food and Cosmetics | 09/24/2025 | Plant construction and design |
| Diamond Jack Enterprises, Inc. | Food and Cosmetics | 09/24/2025 | PCQI training records |
| Digirad Diagnostic Imaging, LLC | Devices | 11/25/2025 | Purchasing controls, Lack of or inadequate procedures |
| Digirad Diagnostic Imaging, LLC | Devices | 11/25/2025 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| E&H Distributors, LLC | Food and Cosmetics | 03/04/2025 | Supplier verification – follow written procedures |
| Ervey Produce, Inc. | Food and Cosmetics | 08/26/2025 | Develop FSVP |
| Evo Kitchen, LLC. | Food and Cosmetics | 06/10/2025 | Personnel |
| Evo Kitchen, LLC. | Food and Cosmetics | 06/10/2025 | Sanitary operations – Plant maintenance |
| Flying Fish MM, LLC | Food and Cosmetics | 01/31/2025 | Develop FSVP |
| Franco Whole Foods, LLC. | Food and Cosmetics | 12/04/2025 | Sanitary operations – Plant maintenance |
| Gate Gourmet | Food and Cosmetics | 02/05/2025 | Personnel |
| Gate Gourmet | Food and Cosmetics | 02/05/2025 | Preventive controls – Implement (Limited Scope only) |
| Gongora USA, Corp. | Food and Cosmetics | 05/21/2025 | Develop FSVP |
| Gongora USA, Corp. | Food and Cosmetics | 05/21/2025 | Hazard analysis biological, chemical, physical |
| Gongora USA, Corp. | Food and Cosmetics | 05/21/2025 | Verification activity assurance |
| Green Star Labs, Inc. | Food and Cosmetics | 02/14/2025 | Hygienic practices |
| Green Star Labs, Inc. | Food and Cosmetics | 02/14/2025 | Specifications – components |
| Green Star Labs, Inc. | Food and Cosmetics | 02/14/2025 | Specifications – finished dietary supplement |
| Green Star Labs, Inc. | Food and Cosmetics | 02/14/2025 | Component – verify identity, dietary ingredient |
| Green Star Labs, Inc. | Food and Cosmetics | 02/14/2025 | Component – qualify supplier |
| Green Star Labs, Inc. | Food and Cosmetics | 02/14/2025 | Master manufacturing record – prepared |
| Green Star Labs, Inc. | Food and Cosmetics | 02/14/2025 | Master manufacturing record – specifications, quality; packaging, labeling |
| Green Star Labs, Inc. | Food and Cosmetics | 02/14/2025 | Batch record – complete |
| Grifols Diagnostic Solutions, Inc. | Biologics | 08/26/2025 | Lack of or inadequate procedures |
| Healthbreads, Inc. | Food and Cosmetics | 12/30/2025 | Sanitary operations – Plant maintenance |
| Healthbreads, Inc. | Food and Cosmetics | 12/30/2025 | Pest control |
| Healthbreads, Inc. | Food and Cosmetics | 12/30/2025 | Manufacturing, processing, packing, holding – Controls |
| Healthbreads, Inc. | Food and Cosmetics | 12/30/2025 | Sanitation preventive controls – Appropriate (Adequate) |
| Healthbreads, Inc. | Veterinary | 12/30/2025 | Sanitary operations – Plant maintenance |
| Healthbreads, Inc. | Veterinary | 12/30/2025 | Pest control |
| Healthbreads, Inc. | Veterinary | 12/30/2025 | Manufacturing, processing, packing, holding – Controls |
| Healthbreads, Inc. | Veterinary | 12/30/2025 | Sanitation preventive controls – Appropriate (Adequate) |
| Hi Technician Electronic Manufacturing Corporation | Devices | 02/06/2025 | Design transfer – Lack of or inadequate procedures |
| Hi Technician Electronic Manufacturing Corporation | Devices | 02/06/2025 | Documentation |
| Hi Technician Electronic Manufacturing Corporation | Devices | 02/06/2025 | Lack of or inadequate DHR procedures |
| Hollandia Dairy, Inc. | Food and Cosmetics | 11/21/2025 | Sanitary facilities and controls |
| Invent Medical Corporation | Devices | 04/23/2025 | Documentation |
| Just About Foods, LLC | Food and Cosmetics | 08/21/2025 | Develop FSVP |
| Just About Foods, LLC | Food and Cosmetics | 08/21/2025 | Verification activity frequency |
| Kabushiki Kaisha Muso Shoji | Food and Cosmetics | 07/30/2025 | Pest control |
| Kabushiki Kaisha Muso Shoji | Food and Cosmetics | 07/30/2025 | Sanitation of food-contact surfaces – Frequency |
| Keith M. Wan, O.D. | Drugs | 06/13/2025 | FD-1572, protocol compliance |
| Keith M. Wan, O.D. | Drugs | 06/13/2025 | Accountability records |
| Keith M. Wan, O.D. | Drugs | 06/13/2025 | Case history records- inadequate or inadequate |
| LM Tropical, LLC | Food and Cosmetics | 08/04/2025 | Supplier verification – establish written procedures |
| LM Tropical, LLC | Food and Cosmetics | 08/04/2025 | Verification activity assurance |
| LM Tropical, LLC | Food and Cosmetics | 08/04/2025 | Verification activity before import, periodically |
| La Fe Tortilleria, Inc. | Food and Cosmetics | 09/23/2025 | Plant construction and design |
| La Fe Tortilleria, Inc. | Food and Cosmetics | 09/23/2025 | Sanitation preventive controls – Implement |
| La Fe Tortilleria, Inc. | Food and Cosmetics | 09/23/2025 | Recall plan – Written |
| La Fe Tortilleria, Inc. | Food and Cosmetics | 09/23/2025 | PCQI training records |
| La Fe Tortilleria, Inc. | Food and Cosmetics | 09/23/2025 | Training records – General requirements |
| La Provence, Inc. | Food and Cosmetics | 11/18/2025 | Sanitary operations – Plant sanitation |
| La Provence, Inc. | Food and Cosmetics | 11/18/2025 | Manufacturing, processing, packing, holding – Controls |
| La Salsa Chilena, Inc. | Food and Cosmetics | 04/30/2025 | Sanitary operations – Plant maintenance |
| La Salsa Chilena, Inc. | Food and Cosmetics | 04/30/2025 | Sanitation of food-contact surfaces – Frequency |
| Life Solutions, Inc. | Food and Cosmetics | 03/03/2025 | Specifications – components |
| Life Solutions, Inc. | Food and Cosmetics | 03/03/2025 | Component – verify identity, dietary ingredient |
| Life Solutions, Inc. | Food and Cosmetics | 03/03/2025 | Component – qualify supplier |
| Life Solutions, Inc. | Food and Cosmetics | 03/03/2025 | Master manufacturing record – record requirements |
| Life Solutions, Inc. | Food and Cosmetics | 03/03/2025 | Sampling plans; establish, follow |
| Med Systems, Inc. | Devices | 03/14/2025 | Acceptable supplier records, inadequate records |
| Mriaudio, Inc. | Devices | 09/05/2025 | Design control – no procedures |
| Mriaudio, Inc. | Devices | 09/05/2025 | Lack of procedures, or not maintained |
| Mriaudio, Inc. | Devices | 09/05/2025 | Lack of or inadequate complaint procedures |
| Myron L Company | Devices | 09/19/2025 | Lack of or inadequate complaint procedures |
| Newton Implant Systems, Inc. | Biologics | 08/18/2025 | Procedures to meet core CTGP |
| Ocean Group, Inc. | Food and Cosmetics | 05/28/2025 | HACCP plan implementation |
| Ocean Group, Inc. | Food and Cosmetics | 05/28/2025 | Critical control points |
| Ocean Group, Inc. | Food and Cosmetics | 05/28/2025 | Records values/observations |
| Ocean Group, Inc. | Food and Cosmetics | 05/28/2025 | Sanitation monitoring |
| Ocean Group, Inc. | Veterinary | 05/28/2025 | HACCP plan implementation |
| Ocean Group, Inc. | Veterinary | 05/28/2025 | Critical control points |
| Ocean Group, Inc. | Veterinary | 05/28/2025 | Records values/observations |
| Ocean Group, Inc. | Veterinary | 05/28/2025 | Sanitation monitoring |
| PCI San Diego, Inc. | Drugs | 05/09/2025 | Procedures not in writing, fully followed |
| PCI San Diego, Inc. | Drugs | 05/09/2025 | Cleaning System |
| PCI San Diego, Inc. | Drugs | 05/09/2025 | Procedures for sterile drug products |
| PCI San Diego, Inc. | Drugs | 05/09/2025 | Validation lacking for sterile drug products |
| PCI San Diego, Inc. | Drugs | 05/09/2025 | Scientifically sound laboratory controls |
| PCI San Diego, Inc. | Drugs | 05/09/2025 | No written record of investigation |
| Pennypacker, LLC | Food and Cosmetics | 03/03/2025 | Specifications – finished dietary supplement |
| Pennypacker, LLC | Food and Cosmetics | 03/03/2025 | Quality control – required operations |
| Pennypacker, LLC | Food and Cosmetics | 03/03/2025 | Master manufacturing record – prepared |
| Perez-Casas Enterprises | Food and Cosmetics | 07/22/2025 | Personnel |
| Perez-Casas Enterprises | Food and Cosmetics | 07/22/2025 | Sanitary operations – Plant sanitation |
| Prosecco Source, LLC | Food and Cosmetics | 09/10/2025 | Develop FSVP |
| Prosecco Source, LLC | Food and Cosmetics | 09/10/2025 | Verification activity assurance |
| Restaurant Depot | Food and Cosmetics | 02/20/2025 | Food safety hazards |
| Restaurant Depot | Food and Cosmetics | 02/20/2025 | Monitoring – adequacy |
| Restaurant Depot | Food and Cosmetics | 02/20/2025 | SSOP(S) |
| Roma Espresso Systems, Inc. | Food and Cosmetics | 03/17/2025 | Manufacturing, processing, packing, holding – Controls |
| Santiago Hernandez Family, LLC | Food and Cosmetics | 07/23/2025 | Sanitary operations – Plant maintenance |
| Santiago Hernandez Family, LLC | Food and Cosmetics | 07/23/2025 | Cleaning and sanitizing substances – Safe and adequate |
| Santiago Hernandez Family, LLC | Food and Cosmetics | 07/23/2025 | Equipment and utensils – Design and maintenance |
| Seven | Food and Cosmetics | 02/26/2025 | Specifications – components |
| Seven | Food and Cosmetics | 02/26/2025 | Specifications – finished dietary supplement |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Computer control of master formula records |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Written warehousing procedures established/followed |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Lab controls established, including changes |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Acceptance of in-process materials |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Test methods |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Documentation of Actual Yield and Theoretical Yield |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Investigations of discrepancies, failures |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Complete test data included in records |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Lack of or inadequate organizational structure |
| Sparsha Pharma Usa, Inc. | Drugs | 09/04/2025 | Documentation |
| Stephen G. Thein, Ph. D. | Drugs | 04/25/2025 | FD-1572, protocol compliance |
| Stephen G. Thein, Ph. D. | Drugs | 04/25/2025 | Changes in research |
| Syntron Bioresearch, Inc. | Devices | 06/02/2025 | Nonconforming product, Lack of or inadequate procedures |
| Syntron Bioresearch, Inc. | Devices | 06/02/2025 | DMR – not or inadequately maintained |
| The Ageless Humans, Inc. | Food and Cosmetics | 03/07/2025 | Specifications – components |
| The Ageless Humans, Inc. | Food and Cosmetics | 03/07/2025 | Written procedures – establish; quality control operations |
| The Ageless Humans, Inc. | Food and Cosmetics | 03/07/2025 | Master manufacturing record – prepared |
| Trade Rooster, Inc. | Food and Cosmetics | 06/03/2025 | Verification activity frequency |
| Trade Rooster, Inc. | Food and Cosmetics | 06/03/2025 | Verification activity before import, periodically |
| Trans-Portes, Inc. | Food and Cosmetics | 09/22/2025 | Hazard analysis written |
| Trans-Portes, Inc. | Food and Cosmetics | 09/22/2025 | Evaluation – performance, risk |
| Trans-Portes, Inc. | Food and Cosmetics | 09/22/2025 | Approved supplier procedures – importer established |
| Trans-Portes, Inc. | Food and Cosmetics | 09/22/2025 | Verification activity assurance |
| Vesalio, Inc. | Devices | 10/30/2025 | Investigation of device failures |
| Vitae Enim Vitae Scientific, Inc. | Drugs | 01/07/2025 | Procedures not in writing, fully followed |
| Vitae Enim Vitae Scientific, Inc. | Drugs | 01/07/2025 | Environmental Monitoring System |
| Vitae Enim Vitae Scientific, Inc. | Drugs | 01/07/2025 | Cleaning System |
| Vitae Enim Vitae Scientific, Inc. | Drugs | 01/07/2025 | Equipment Design, Size and Location |
| Vitae Enim Vitae Scientific, Inc. | Drugs | 01/07/2025 | Establishment of time limitations |
| Vitae Enim Vitae Scientific, Inc. | Drugs | 01/07/2025 | Validation lacking for sterile drug products |
| Vitae Enim Vitae Scientific, Inc. | Drugs | 01/07/2025 | Extent of discrepancy, failure investigations |
| Vitae Enim Vitae Scientific, Inc. | Veterinary | 01/07/2025 | Procedures not in writing, fully followed |
| Vitae Enim Vitae Scientific, Inc. | Veterinary | 01/07/2025 | Environmental Monitoring System |
| Vitae Enim Vitae Scientific, Inc. | Veterinary | 01/07/2025 | Cleaning System |
| Vitae Enim Vitae Scientific, Inc. | Veterinary | 01/07/2025 | Equipment Design, Size and Location |
| Vitae Enim Vitae Scientific, Inc. | Veterinary | 01/07/2025 | Establishment of time limitations |
| Vitae Enim Vitae Scientific, Inc. | Veterinary | 01/07/2025 | Validation lacking for sterile drug products |
| Vitae Enim Vitae Scientific, Inc. | Veterinary | 01/07/2025 | Extent of discrepancy, failure investigations |
| Vitrolife, Inc. | Devices | 01/23/2025 | Review and evaluation for investigation |
| Willow Glen Consultancy, LLC | Food and Cosmetics | 10/22/2025 | Hazard analysis written |
| Willow Glen Consultancy, LLC | Food and Cosmetics | 10/22/2025 | Verification activity before import, periodically |
| Zamzam Food | Food and Cosmetics | 04/30/2025 | Develop FSVP |
| Zmicro, Inc. | Devices | 10/16/2025 | GUDID Information required for unique device identification. |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
