There were 49 companies in cities associated with Orange County that received FDA citations as a result of 49 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 27.9% decrease from the number of companies cited in the previous year.
Of the 166 citations issued, the most common citation was ‘You did not take a reasonable measure or precaution related to personnel practices’.
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.
Of the companies cited, 45 should take voluntary actions to correct their managing operations (91.8%). Additionally, four companies had to take regulatory and/or administrative actions (8.2%).
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 Orange County Cities and the Citations They Received in 2024
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Acadian Fish Company, LLC | Food and Cosmetics | 07/17/2024 | Sanitary facilities and controls |
| Acadian Fish Company, LLC | Food and Cosmetics | 07/17/2024 | HACCP plan implementation |
| Acadian Fish Company, LLC | Food and Cosmetics | 07/17/2024 | Importer verification |
| Apnea Sciences Corporation | Devices | 09/18/2024 | Design changes – Lack of or Inadequate Procedures |
| Apnea Sciences Corporation | Devices | 09/18/2024 | Lack of or inadequate complaint procedures |
| Ari’S Wholesale, LLC | Food and Cosmetics | 05/15/2024 | Evaluation – performance, risk |
| Ari’S Wholesale, LLC | Food and Cosmetics | 05/15/2024 | Verification activity assurance |
| Ari’S Wholesale, LLC | Food and Cosmetics | 05/15/2024 | Verification activity frequency |
| Ari’S Wholesale, LLC | Food and Cosmetics | 05/15/2024 | Audit – food safety regulation, plan |
| Bar None, Inc. | Food and Cosmetics | 07/10/2024 | Allergen preventive controls – Identify (Written) |
| Bar None, Inc. | Food and Cosmetics | 07/10/2024 | Process preventive controls – Identify (Written) |
| Bar None, Inc. | Food and Cosmetics | 07/10/2024 | Sanitation preventive controls – Identify (Written) |
| Bar None, Inc. | Food and Cosmetics | 07/10/2024 | Process preventive controls – Appropriate (Adequate) |
| Barohup, Inc. | Food and Cosmetics | 02/22/2024 | Develop FSVP |
| Barohup, Inc. | Food and Cosmetics | 02/22/2024 | Supplier approval – document |
| Barohup, Inc. | Food and Cosmetics | 02/22/2024 | Continue to import, change activities |
| Barohup, Inc. | Food and Cosmetics | 02/22/2024 | Approved supplier procedures – follow, document use |
| Barohup, Inc. | Food and Cosmetics | 02/22/2024 | Onsite audit |
| Barohup, Inc. | Food and Cosmetics | 02/22/2024 | Investigate |
| BioDuro, LLC | Drugs | 02/23/2024 | Procedures not in writing, fully followed |
| BioDuro, LLC | Drugs | 02/23/2024 | Equipment Design, Size and Location |
| BioDuro, LLC | Drugs | 02/23/2024 | Absence of Written Procedures |
| BioDuro, LLC | Drugs | 02/23/2024 | Scientifically sound laboratory controls |
| BioDuro, LLC | Drugs | 02/23/2024 | Testing and release for distribution |
| BioDuro, LLC | Drugs | 02/23/2024 | Acceptance criteria for sampling & testing |
| BioDuro, LLC | Drugs | 02/23/2024 | Records reviewed annually |
| BioDuro, LLC | Drugs | 02/23/2024 | Investigations of discrepancies, failures |
| Biogennix, LLC | Devices | 02/08/2024 | Nonconforming product, Lack of or inadequate procedures |
| Biogennix, LLC | Devices | 02/08/2024 | Lack of or inadequate procedures |
| Biogennix, LLC | Devices | 02/08/2024 | Complaints |
| Children’s Hospital of Orange County | Biologics | 01/16/2024 | Establish, maintain and follow manufacturing SOPs |
| Children’s Hospital of Orange County | Biologics | 01/16/2024 | Concurrent documentation |
| Daiso USA, LLC | Food and Cosmetics | 07/17/2024 | Hazard analysis biological, chemical, physical |
| EM Tortillas, LLC | Food and Cosmetics | 11/05/2024 | Sanitary operations – Plant maintenance |
| EM Tortillas, LLC | Food and Cosmetics | 11/05/2024 | Sanitary facilities and controls |
| EM Tortillas, LLC | Food and Cosmetics | 11/05/2024 | Food safety plan |
| Evoqua Water Technologies, LLC | Devices | 05/14/2024 | Label to bear a unique device identifier |
| Evoqua Water Technologies, LLC | Devices | 05/14/2024 | Quality Audits – defined intervals |
| Evoqua Water Technologies, LLC | Devices | 05/14/2024 | DHR content |
| Evoqua Water Technologies, LLC | Devices | 05/14/2024 | Devices subject to device identification GUDID data submission requirements. |
| Excelsior Nutrition, Inc. | Food and Cosmetics | 05/23/2024 | Corrective action plans |
| Fertility Care of Orange County, A Medical Corporation | Biologics | 10/07/2024 | Risk factors, clinical evidence |
| Flavorchem Corporation | Food and Cosmetics | 02/07/2024 | Plant operations – Precautions |
| G. M. J. Natural Products, Inc. | Food and Cosmetics | 08/28/2024 | Written procedures – establish; quality control operations |
| G. M. J. Natural Products, Inc. | Food and Cosmetics | 08/28/2024 | Written procedures – establish; returned dietary supplements |
| G. M. J. Natural Products, Inc. | Food and Cosmetics | 08/28/2024 | Records – written procedures; product complaint |
| GMP Laboratories of America, Inc. | Drugs | 12/16/2024 | Cleaning SOPs/instructions |
| GMP Laboratories of America, Inc. | Drugs | 12/16/2024 | Absence of Written Procedures |
| GMP Laboratories of America, Inc. | Drugs | 12/16/2024 | SOPs not followed / documented |
| GMP Laboratories of America, Inc. | Drugs | 12/16/2024 | Complete test data included in records |
| Genuine Virgin Aloe, Corp. | Drugs | 01/29/2024 | Procedures not in writing, fully followed |
| Genuine Virgin Aloe, Corp. | Drugs | 01/29/2024 | Training , Education , Experience overall |
| Genuine Virgin Aloe, Corp. | Drugs | 01/29/2024 | Equipment Design, Size and Location |
| Genuine Virgin Aloe, Corp. | Drugs | 01/29/2024 | Reports of Analysis (Components) |
| Genuine Virgin Aloe, Corp. | Drugs | 01/29/2024 | Absence of Written Procedures |
| Genuine Virgin Aloe, Corp. | Drugs | 01/29/2024 | Lack of written stability program |
| Genuine Virgin Aloe, Corp. | Drugs | 01/29/2024 | Records reviewed annually |
| Genuine Virgin Aloe, Corp. | Drugs | 01/29/2024 | Prepared for each batch, include complete information |
| Greenfruit Avocados, LLC | Food and Cosmetics | 01/18/2024 | Evaluation – performance, risk |
| Greenfruit Avocados, LLC | Food and Cosmetics | 01/18/2024 | Approved supplier procedures – importer established |
| Greenfruit Avocados, LLC | Food and Cosmetics | 01/18/2024 | Audit – food safety regulation, plan |
| Harris Spice Company, Inc. | Food and Cosmetics | 04/19/2024 | Personnel |
| Huntington Reproductive Center Medical Group | Biologics | 10/29/2024 | Determination based on screening and testing |
| Huntington Reproductive Center Medical Group | Biologics | 10/29/2024 | Name and personal info on accompanying records |
| Interfresh, Inc. | Food and Cosmetics | 04/30/2024 | Evaluation – performance, risk |
| Interfresh, Inc. | Food and Cosmetics | 04/30/2024 | Audit – food safety regulation, plan |
| Japonaise Bakery | Food and Cosmetics | 03/29/2024 | Personnel |
| Japonaise Bakery | Food and Cosmetics | 03/29/2024 | Sanitary operations – Plant maintenance |
| Japonaise Bakery | Food and Cosmetics | 03/29/2024 | Pest control |
| Japonaise Bakery | Food and Cosmetics | 03/29/2024 | Sanitation of food-contact surfaces – Frequency |
| Japonaise Bakery | Food and Cosmetics | 03/29/2024 | Equipment and utensils – Design and maintenance |
| Japonaise Bakery | Food and Cosmetics | 03/29/2024 | Storage and Distribution |
| Kelley’s, Inc. | Food and Cosmetics | 02/20/2024 | Cleaning and sanitizing substances – Safe and adequate |
| Kelley’s, Inc. | Food and Cosmetics | 02/20/2024 | Sanitary facilities and controls |
| Kelley’s, Inc. | Food and Cosmetics | 02/20/2024 | Equipment and utensils – Design and maintenance |
| Kelley’s, Inc. | Food and Cosmetics | 02/20/2024 | Manufacturing, processing, packing, holding – Controls |
| LGM Pharma Solutions, LLC | Drugs | 03/01/2024 | Procedures not in writing, fully followed |
| LGM Pharma Solutions, LLC | Drugs | 03/01/2024 | Written procedures not established/followed |
| LGM Pharma Solutions, LLC | Drugs | 03/01/2024 | Absence of Written Procedures |
| LGM Pharma Solutions, LLC | Drugs | 03/01/2024 | Deviations from laboratory control requirements |
| LQNN, Inc. | Food and Cosmetics | 06/20/2024 | Personnel |
| LQNN, Inc. | Food and Cosmetics | 06/20/2024 | Storage and Distribution |
| Lawrence Werlin, Inc., M.D. | Biologics | 06/26/2024 | Determination based on screening and testing |
| Lawrence Werlin, Inc., M.D. | Biologics | 06/26/2024 | Completion of eligibility determination |
| M. R. S. Foods, Inc. | Food and Cosmetics | 10/04/2024 | Personnel |
| M. R. S. Foods, Inc. | Food and Cosmetics | 10/04/2024 | Sanitation of food-contact surfaces – Frequency |
| M. R. S. Foods, Inc. | Food and Cosmetics | 10/04/2024 | Equipment and utensils – Design and maintenance |
| Medicatech Usa | Devices | 10/22/2024 | Design transfer – Lack of or inadequate procedures |
| Medicatech Usa | Devices | 10/22/2024 | Lack of or inadequate complaint procedures |
| Medicatech Usa | Devices | 10/22/2024 | Devices subject to device identification GUDID data submission requirements. |
| Medipines Corporation | Devices | 01/22/2024 | Lack of or inadequate process validation |
| Medipines Corporation | Devices | 01/22/2024 | Lack of or inadequate procedures |
| Medipines Corporation | Devices | 01/22/2024 | Lack of or inadequate complaint procedures |
| MeriCal, LLC | Food and Cosmetics | 12/19/2024 | Hygienic practices |
| MeriCal, LLC | Food and Cosmetics | 12/19/2024 | Equipment – design – appropriate and suitable |
| MeriCal, LLC | Food and Cosmetics | 12/19/2024 | Specifications – components |
| MeriCal, LLC | Food and Cosmetics | 12/19/2024 | Specifications – finished dietary supplement |
| MeriCal, LLC | Food and Cosmetics | 12/19/2024 | Quality control – reject; specification not met |
| MeriCal, LLC | Food and Cosmetics | 12/19/2024 | Components – contamination, deterioration, mix-ups |
| MeriCal, LLC | Food and Cosmetics | 12/19/2024 | Master manufacturing record – record requirements |
| MeriCal, LLC | Food and Cosmetics | 12/19/2024 | Batch record – required information |
| Micro Precision Swiss, LLC | Devices | 09/12/2024 | Lack of or inadequate In-process acceptance procedures |
| Micro Precision Swiss, LLC | Devices | 09/12/2024 | Lack of or inadequate procedures |
| NIPPN California, Inc. | Food and Cosmetics | 04/12/2024 | Disclosure – customer subject cGMP |
| NRS Enterprises, Inc. | Food and Cosmetics | 03/06/2024 | Sanitary operations – Plant maintenance |
| NRS Enterprises, Inc. | Food and Cosmetics | 03/06/2024 | Pest control |
| NRS Enterprises, Inc. | Food and Cosmetics | 03/06/2024 | Sanitation of food-contact surfaces – Frequency |
| NRS Enterprises, Inc. | Food and Cosmetics | 03/06/2024 | Sanitation of non-food-contact surfaces – Manner and frequency |
| NRS Enterprises, Inc. | Food and Cosmetics | 03/06/2024 | Equipment and utensils – Design and maintenance |
| NRS Enterprises, Inc. | Food and Cosmetics | 03/06/2024 | Storage and Distribution |
| NRS Enterprises, Inc. | Food and Cosmetics | 03/06/2024 | Food safety plan |
| National Medical Products, Inc. | Devices | 05/30/2024 | Lack of or inadequate procedures |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Individual Report of Malfunction |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Training – Lack of or inadequate procedures |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Design output – Lack of or inadequate procedures |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Design verification – output does not meet input requirement |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Design validation – production units |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Design Validation – Risk analysis not performed/inadequate |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Design transfer – Lack of or inadequate procedures |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Design changes – Lack of or Inadequate Procedures |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Lack of or inadequate process validation |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Acceptance status |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Nonconforming product, Lack of or inadequate procedures |
| NuVasive Specialized Orthopedics, Inc. | Devices | 05/06/2024 | Lack of or inadequate procedures |
| Orange Bakery, Inc. | Food and Cosmetics | 12/04/2024 | Personnel |
| Orange Bakery, Inc. | Food and Cosmetics | 12/04/2024 | Sanitation of food-contact surfaces – Frequency |
| Orange Bakery, Inc. | Food and Cosmetics | 12/04/2024 | Equipment and utensils – Design and maintenance |
| Pacific Reproductive Center, Inc. | Biologics | 08/19/2024 | Determination based on screening and testing |
| ProTab Laboratories | Food and Cosmetics | 05/22/2024 | Quality control – components, approve, release |
| Pura Vida Farms, LLC | Food and Cosmetics | 09/10/2024 | Evaluation – performance, risk |
| Pura Vida Farms, LLC | Food and Cosmetics | 09/10/2024 | Supplier verification – establish written procedures |
| Pura Vida Farms, LLC | Food and Cosmetics | 09/10/2024 | Verification activity assurance |
| Q’s AMERICAN BEST TRADING, Inc. | Food and Cosmetics | 06/13/2024 | Develop FSVP |
| Quasar Bio-Technician, Inc. | Devices | 12/20/2024 | Quality Audits – defined intervals |
| Quasar Bio-Technician, Inc. | Devices | 12/20/2024 | Lack of procedures, or not maintained |
| Quasar Bio-Technician, Inc. | Devices | 12/20/2024 | Supplier notification of changes |
| Quasar Bio-Technician, Inc. | Devices | 12/20/2024 | Lack of or inadequate complaint procedures |
| Sanitor Corporation | Drugs | 05/10/2024 | Results not used for expiration dates, storage cond. |
| Sanitor Corporation | Drugs | 05/10/2024 | Investigations of discrepancies, failures |
| St. Tea/Good Won Foods, LLC | Food and Cosmetics | 04/18/2024 | Develop FSVP |
| Super Beta Glucan, Inc. | Food and Cosmetics | 01/26/2024 | Specifications – labels, packaging |
| Super Beta Glucan, Inc. | Food and Cosmetics | 01/26/2024 | Written procedures – quality control operations |
| Super Beta Glucan, Inc. | Food and Cosmetics | 01/26/2024 | Master manufacturing record – each batch |
| Super Beta Glucan, Inc. | Food and Cosmetics | 01/26/2024 | Written procedures – product complaint |
| Thanh Son Tofu, Inc. | Food and Cosmetics | 07/15/2024 | Personnel |
| Thanh Son Tofu, Inc. | Food and Cosmetics | 07/15/2024 | Sanitary operations – Plant maintenance |
| Thanh Son Tofu, Inc. | Food and Cosmetics | 07/15/2024 | Pest control |
| Thanh Son Tofu, Inc. | Food and Cosmetics | 07/15/2024 | Sanitary facilities and controls |
| Thanh Son Tofu, Inc. | Food and Cosmetics | 07/15/2024 | Equipment and utensils – Design and maintenance |
| Thanh Son Tofu, Inc. | Food and Cosmetics | 07/15/2024 | Storage and Distribution |
| Thanh Son Tofu, Inc. | Veterinary | 07/15/2024 | Personnel |
| Thanh Son Tofu, Inc. | Veterinary | 07/15/2024 | Sanitary operations – Plant maintenance |
| Thanh Son Tofu, Inc. | Veterinary | 07/15/2024 | Pest control |
| Thanh Son Tofu, Inc. | Veterinary | 07/15/2024 | Sanitary facilities and controls |
| Thanh Son Tofu, Inc. | Veterinary | 07/15/2024 | Equipment and utensils – Design and maintenance |
| Thanh Son Tofu, Inc. | Veterinary | 07/15/2024 | Storage and Distribution |
| University of California Irvine Medical Center Campus Donor Center | Biologics | 05/15/2024 | Establish, maintain and follow manufacturing SOPs |
| University of California Irvine Medical Center Campus Donor Center | Biologics | 05/15/2024 | Thorough investigations |
| University of California Irvine Medical Center Campus Donor Center | Biologics | 05/15/2024 | Proof Of Identity |
| VBS Distribution, Inc. | Food and Cosmetics | 04/18/2024 | Quality control – finished batch, distribution |
| VBS Distribution, Inc. | Food and Cosmetics | 04/18/2024 | Written procedures – holding |
| VBS Distribution, Inc. | Food and Cosmetics | 04/18/2024 | Records – returned dietary supplement: written procedures |
| VBS Distribution, Inc. | Food and Cosmetics | 04/18/2024 | Written procedures – product complaint |
| Veg-Land, Inc. | Food and Cosmetics | 08/28/2024 | Equipment and utensils – Design and maintenance |
| Veg-Land, Inc. | Veterinary | 08/28/2024 | Equipment and utensils – Design and maintenance |
| Ventura Produce, LLC | Food and Cosmetics | 02/22/2024 | Develop FSVP |
