There were 39 companies in cities associated with Alameda County that received FDA citations as a result of 40 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 32.8% decrease from the number of companies cited in the previous year.
Of the 99 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.
Of the companies cited, 37 should take voluntary actions to correct their managing operations (94.9%). Additionally, two companies had to take regulatory and/or administrative actions (5.1%).
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.
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, according to its website.
Companies Located Within Alameda County Cities and the Citations They Received in 2023
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Hazard analysis biological, chemical, physical |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Document review entity’s hazard analysis |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Supplier approval – document |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Approved supplier procedures – importer established |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Supplier verification – establish written procedures |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Verification activity assurance |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Verification activity before import, periodically |
| AMO and Wing, Inc. | Food and Cosmetics | 02/13/2023 | Develop FSVP |
| Acorn Trading, Inc. | Food and Cosmetics | 10/23/2023 | Qualifications of individuals |
| Acorn Trading, Inc. | Food and Cosmetics | 10/23/2023 | Storage and Distribution |
| African Caribbean Food Market | Food and Cosmetics | 04/17/2023 | Develop FSVP |
| African Caribbean Food Market | Food and Cosmetics | 04/17/2023 | Very small importer assurances, supplier |
| Akshar Sales, LLC | Food and Cosmetics | 02/15/2023 | Develop FSVP |
| Ardelyx, Inc. | Drugs | 07/24/2023 | Failure to develop written procedures |
| Bake Fresh of Northern California, LLC | Food and Cosmetics | 11/16/2023 | Personnel |
| Bake Fresh of Northern California, LLC | Food and Cosmetics | 11/16/2023 | Sanitation of food-contact surfaces – Frequency |
| Bake Fresh of Northern California, LLC | Food and Cosmetics | 11/16/2023 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Bake Fresh of Northern California, LLC | Food and Cosmetics | 11/16/2023 | Raw materials control – Microorganisms |
| Challenge Dairy Products – SF, Inc. | Food and Cosmetics | 02/13/2023 | Modified requirement: Temperature control – Implement |
| Come On, Inc. | Food and Cosmetics | 08/07/2023 | Develop FSVP |
| Fijian Wholesale Company | Food and Cosmetics | 05/04/2023 | Develop FSVP |
| Fijian Wholesale Company | Food and Cosmetics | 05/04/2023 | Hazard analysis biological, chemical, physical |
| Fitsum Ghebremichael Amare | Food and Cosmetics | 04/05/2023 | Develop FSVP |
| Five Crops International, Inc. | Food and Cosmetics | 07/28/2023 | Develop FSVP |
| Galant Enterprises, Inc. | Food and Cosmetics | 04/20/2023 | Sanitary operations – Plant sanitation |
| Galant Enterprises, Inc. | Food and Cosmetics | 04/20/2023 | Hazard analysis – Identification of hazard |
| Gourmand Artisan Foods | Food and Cosmetics | 05/09/2023 | Sanitary facilities and controls |
| Guru Distributors, Inc. | Food and Cosmetics | 01/25/2023 | Develop FSVP |
| Happy Royal North America | Food and Cosmetics | 01/27/2023 | Develop FSVP |
| Hong Hae USA, Inc. | Food and Cosmetics | 07/31/2023 | Develop FSVP |
| Hong Hae USA, Inc. | Food and Cosmetics | 07/31/2023 | Evaluation – performance, risk |
| Hong Hae USA, Inc. | Food and Cosmetics | 07/31/2023 | Verification activity before import, periodically |
| JFC International, Inc. | Food and Cosmetics | 11/20/2023 | No HACCP plan |
| JFC International, Inc. | Food and Cosmetics | 11/20/2023 | Monitoring – adequacy |
| Jaymin Enterprises, Corp. | Food and Cosmetics | 02/21/2023 | Develop FSVP |
| Kermit Lynch Wine Merchant | Food and Cosmetics | 09/19/2023 | Hazard analysis written |
| Kermit Lynch Wine Merchant | Food and Cosmetics | 09/19/2023 | Supplier approval – document |
| Kermit Lynch Wine Merchant | Food and Cosmetics | 09/19/2023 | Verification activity assurance |
| Kermit Lynch Wine Merchant | Food and Cosmetics | 09/19/2023 | Verification activity before import, periodically |
| Khong Guan Corporation | Food and Cosmetics | 06/06/2023 | Hazard analysis written |
| Khong Guan Corporation | Food and Cosmetics | 06/06/2023 | Verification activity frequency |
| Living Tree Community Foods | Food and Cosmetics | 03/17/2023 | Personnel |
| Living Tree Community Foods | Food and Cosmetics | 03/17/2023 | Sanitation of food-contact surfaces – Frequency |
| Living Tree Community Foods | Food and Cosmetics | 03/17/2023 | Hazard analysis – Identification of hazard |
| Mangal’s Markets | Food and Cosmetics | 04/27/2023 | Develop FSVP |
| Mangal’s Markets | Food and Cosmetics | 04/27/2023 | Verification activity before import, periodically |
| Mariposa Baking Company | Food and Cosmetics | 02/13/2023 | Personnel |
| Mariposa Baking Company | Food and Cosmetics | 02/13/2023 | Raw materials – Allergen identification |
| New Horizon Enterprises, Ltd. | Food and Cosmetics | 05/17/2023 | Grounds |
| New Horizon Enterprises, Ltd. | Food and Cosmetics | 05/17/2023 | Pest control |
| Organic Spices, Inc. | Food and Cosmetics | 10/24/2023 | Personnel |
| Organic Spices, Inc. | Food and Cosmetics | 10/24/2023 | Sanitary facilities and controls |
| Pacific Star Produce, LLC | Food and Cosmetics | 08/15/2023 | Develop FSVP |
| Pepcol International Foods | Food and Cosmetics | 03/28/2023 | LACF compliance |
| Pepcol International Foods | Food and Cosmetics | 03/28/2023 | Hazard analysis biological, chemical, physical |
| Pepcol International Foods | Food and Cosmetics | 03/28/2023 | Supplier approval – document |
| Pepcol International Foods | Food and Cosmetics | 03/28/2023 | Verification activity frequency |
| Phong Kee Company, LLC | Food and Cosmetics | 07/13/2023 | Sanitary operations – Plant maintenance |
| Phong Kee Company, LLC | Food and Cosmetics | 07/13/2023 | Cleaning and sanitizing substances – Safe and adequate |
| Phong Kee Company, LLC | Food and Cosmetics | 07/13/2023 | Equipment and utensils – Design and maintenance |
| Phong Kee Company, LLC | Food and Cosmetics | 07/13/2023 | Manufacturing, processing, packing, holding – Controls |
| Reliance Indian Grocery | Food and Cosmetics | 03/07/2023 | Develop FSVP |
| Reliance Indian Grocery | Food and Cosmetics | 03/07/2023 | Evaluation – performance, risk |
| Reliance Indian Grocery | Food and Cosmetics | 03/07/2023 | Supplier approval – document |
| Reliance Indian Grocery | Food and Cosmetics | 03/07/2023 | Supplier verification – establish written procedures |
| Sai Nakshatra Investment, Inc. | Food and Cosmetics | 07/13/2023 | Develop FSVP |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Develop FSVP |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Hazard analysis written |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Hazard analysis biological, chemical, physical |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Evaluation – performance, risk |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Supplier approval – document |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Supplier verification – establish written procedures |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Verification activity frequency |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Verification activity – appropriate |
| Shrinath Trading, LLC | Food and Cosmetics | 05/03/2023 | Verification activity before import, periodically |
| Softap, Inc. | Drugs | 12/11/2023 | Procedures not in writing, fully followed |
| Softap, Inc. | Drugs | 12/11/2023 | Training–operations, GMPs, written procedures |
| Softap, Inc. | Drugs | 12/11/2023 | Written distribution procedure |
| Softap, Inc. | Drugs | 12/11/2023 | Reserve samples identified, representative, stored |
| Softap, Inc. | Drugs | 12/11/2023 | Records reviewed annually |
| Softap, Inc. | Drugs | 12/11/2023 | Prepared for each batch, include complete information |
| Softap, Inc. | Drugs | 12/11/2023 | Complaint Handling Procedure |
| TP Lin, Inc. | Food and Cosmetics | 08/07/2023 | Document review entity’s hazard analysis |
| TP Lin, Inc. | Food and Cosmetics | 08/07/2023 | Evaluation – performance, risk |
| TP Lin, Inc. | Food and Cosmetics | 08/07/2023 | Approved supplier procedures – importer established |
| TP Lin, Inc. | Food and Cosmetics | 08/07/2023 | Verification activity assurance |
| The Healthy Baking Company, LLC | Food and Cosmetics | 07/28/2023 | Manufacturing, processing, packing, holding – Controls |
| Trans Pacific Assets Management, Corp. | Food and Cosmetics | 08/21/2023 | Hazard analysis biological, chemical, physical |
| Trans Pacific Assets Management, Corp. | Food and Cosmetics | 08/21/2023 | Document review entity’s hazard analysis |
| Trans Pacific Assets Management, Corp. | Food and Cosmetics | 08/21/2023 | Evaluation – performance, risk |
| Trans Pacific Assets Management, Corp. | Food and Cosmetics | 08/21/2023 | Approved supplier procedures – importer established |
| Trans Pacific Assets Management, Corp. | Food and Cosmetics | 08/21/2023 | Verification activity assurance |
| Trans Pacific Assets Management, Corp. | Food and Cosmetics | 08/21/2023 | Verification activity before import, periodically |
| Two Bros Food, Inc. | Food and Cosmetics | 04/17/2023 | Develop FSVP |
| U. F. Union International Food, Inc. | Food and Cosmetics | 10/17/2023 | Personnel |
| U. S. Import Export Corporation | Food and Cosmetics | 04/27/2023 | Toxic chemicals – Identified, held, stored |
| U. S. Import Export Corporation | Food and Cosmetics | 04/27/2023 | Pest control |
| U. S. Tov, Inc. | Food and Cosmetics | 06/27/2023 | Hazard analysis written |
| U. S. Tov, Inc. | Food and Cosmetics | 06/27/2023 | Reevaluate – 3 years |
