There were 14 companies in cities associated with Orange County that received FDA citations as a result of 14 inspections conducted in the county in 2024, according to the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
Of the 49 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 Drugs sector.
Of the companies cited, 13 should take voluntary actions to correct their managing operations (92.9%). Additionally, one company had to take regulatory and/or administrative actions (7.1%).
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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Forest Coffee, LLC | Food and Cosmetics | 04/05/2024 | Develop FSVP |
| Forest Coffee, LLC | Food and Cosmetics | 04/05/2024 | Identification – entry |
| Freshfields Farms, Inc. | Food and Cosmetics | 07/26/2024 | Develop FSVP |
| Fruitage Trade and Commodities, LLC. | Food and Cosmetics | 11/01/2024 | Develop FSVP |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Lack of or inadequate organizational structure |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Management review – Lack of or inadequate procedures |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Quality audits – Lack of or inadequate procedures |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Procedures not adequately established or maintained |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Purchasing controls, Lack of or inadequate procedures |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Identification procedures, Lack of or inadequate procedures |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Maintenance schedule, Lack of or inadequate schedule |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Lack of or inadequate procedures – Acceptance activities |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Nonconforming product, Lack of or inadequate procedures |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Lack of or inadequate procedures |
| GPS Dental Lab, Inc. | Devices | 11/05/2024 | Lack of or inadequate complaint procedures |
| Hemani Herbal, LLC | Food and Cosmetics | 03/01/2024 | Hazard analysis biological, chemical, physical |
| Joy Produce, LLC | Food and Cosmetics | 06/05/2024 | Evaluation – performance, risk |
| Joy Produce, LLC | Food and Cosmetics | 06/05/2024 | Verification activity before import, periodically |
| Jubilant DraxImage Radiopharmacies, Inc. | Drugs | 03/13/2024 | Aseptic processing outside ISO 5 area |
| Jubilant DraxImage Radiopharmacies, Inc. | Drugs | 03/13/2024 | Inadequate smoke studies |
| Jubilant DraxImage Radiopharmacies, Inc. | Drugs | 03/13/2024 | Lack of/inadequate, environmental monitoring |
| Jubilant DraxImage Radiopharmacies, Inc. | Drugs | 03/13/2024 | Media fills, failure |
| Jubilant DraxImage Radiopharmacies, Inc. | Drugs | 03/13/2024 | Non-sterile disinfecting agents, ISO 5 area/classified areas |
| Jubilant DraxImage Radiopharmacies, Inc. | Drugs | 03/13/2024 | Personnel, blocked or disrupted first air |
| La Chocolaterie, LLC | Food and Cosmetics | 12/12/2024 | Written procedures – establish; personnel |
| La Chocolaterie, LLC | Food and Cosmetics | 12/12/2024 | Written procedures – establish; cleaning |
| La Chocolaterie, LLC | Food and Cosmetics | 12/12/2024 | Written procedures – establish; holding and distribution |
| McLane Food Service Distribution | Food and Cosmetics | 01/10/2024 | Hazard analysis written |
| McLane Food Service Distribution | Food and Cosmetics | 01/10/2024 | Approved supplier procedures – follow, document use |
| McLane Food Service Distribution | Food and Cosmetics | 01/10/2024 | Identification – entry |
| Profounda, Inc. | Drugs | 08/30/2024 | Procedures not in writing, fully followed |
| Profounda, Inc. | Drugs | 08/30/2024 | Cleaning / Sanitizing / Maintenance |
| Profounda, Inc. | Drugs | 08/30/2024 | Scientifically sound laboratory controls |
| Profounda, Inc. | Drugs | 08/30/2024 | Complaint Handling Procedure |
| Salon Technologies International, Inc. | Drugs | 09/20/2024 | Procedures not in writing, fully followed |
| Salon Technologies International, Inc. | Drugs | 09/20/2024 | Equipment Design, Size and Location |
| Salon Technologies International, Inc. | Drugs | 09/20/2024 | Identity Testing of Each Component |
| Selery Fulfillment | Food and Cosmetics | 05/31/2024 | Written procedures – holding |
| Selery Fulfillment | Food and Cosmetics | 05/31/2024 | Records – returned dietary supplement: written procedures |
| Super Nova Refrigerated Transport, Inc. | Food and Cosmetics | 05/09/2024 | Develop FSVP |
| Xymogen Manufacturing, LLC | Food and Cosmetics | 08/13/2024 | Specifications – components |
| Xymogen Manufacturing, LLC | Food and Cosmetics | 08/13/2024 | Specifications – finished dietary supplement |
| Xymogen Manufacturing, LLC | Food and Cosmetics | 08/13/2024 | Documentation specifications met; exempted, periodic testing |
| Xymogen Manufacturing, LLC | Food and Cosmetics | 08/13/2024 | Master manufacturing record – prepared |
| Xymogen Manufacturing, LLC | Food and Cosmetics | 08/13/2024 | Master manufacturing record – record requirements |
| Xymogen Manufacturing, LLC | Food and Cosmetics | 08/13/2024 | Standard reference materials; criteria for selecting |
| Xymogen Manufacturing, LLC | Food and Cosmetics | 08/13/2024 | Examination, testing; established criteria |
| Xymogen Manufacturing, LLC | Food and Cosmetics | 08/13/2024 | Examination, testing; scientifically valid |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
