South Alameda News

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.

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