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Thursday, November 14, 2024

How many companies in cities across Alameda County received FDA citations in 2023?

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

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 NameArea of BusinessInspection DateIssue Cited
AMO and Wing, Inc.Food and Cosmetics12/06/2023Hazard analysis biological, chemical, physical
AMO and Wing, Inc.Food and Cosmetics12/06/2023Document review entity's hazard analysis
AMO and Wing, Inc.Food and Cosmetics12/06/2023Supplier approval - document
AMO and Wing, Inc.Food and Cosmetics12/06/2023Approved supplier procedures - importer established
AMO and Wing, Inc.Food and Cosmetics12/06/2023Supplier verification - establish written procedures
AMO and Wing, Inc.Food and Cosmetics12/06/2023Verification activity assurance
AMO and Wing, Inc.Food and Cosmetics12/06/2023Verification activity before import, periodically
AMO and Wing, Inc.Food and Cosmetics02/13/2023Develop FSVP
Acorn Trading, Inc.Food and Cosmetics10/23/2023Qualifications of individuals
Acorn Trading, Inc.Food and Cosmetics10/23/2023Storage and Distribution
African Caribbean Food MarketFood and Cosmetics04/17/2023Develop FSVP
African Caribbean Food MarketFood and Cosmetics04/17/2023Very small importer assurances, supplier
Akshar Sales, LLCFood and Cosmetics02/15/2023Develop FSVP
Ardelyx, Inc.Drugs07/24/2023Failure to develop written procedures
Bake Fresh of Northern California, LLCFood and Cosmetics11/16/2023Personnel
Bake Fresh of Northern California, LLCFood and Cosmetics11/16/2023Sanitation of food-contact surfaces - Frequency
Bake Fresh of Northern California, LLCFood and Cosmetics11/16/2023Sanitation of non-food-contact surfaces - Manner and frequency
Bake Fresh of Northern California, LLCFood and Cosmetics11/16/2023Raw materials control - Microorganisms
Challenge Dairy Products - SF, Inc.Food and Cosmetics02/13/2023Modified requirement: Temperature control - Implement
Come On, Inc.Food and Cosmetics08/07/2023Develop FSVP
Fijian Wholesale CompanyFood and Cosmetics05/04/2023Develop FSVP
Fijian Wholesale CompanyFood and Cosmetics05/04/2023Hazard analysis biological, chemical, physical
Fitsum Ghebremichael AmareFood and Cosmetics04/05/2023Develop FSVP
Five Crops International, Inc.Food and Cosmetics07/28/2023Develop FSVP
Galant Enterprises, Inc.Food and Cosmetics04/20/2023Sanitary operations - Plant sanitation
Galant Enterprises, Inc.Food and Cosmetics04/20/2023Hazard analysis - Identification of hazard
Gourmand Artisan FoodsFood and Cosmetics05/09/2023Sanitary facilities and controls
Guru Distributors, Inc.Food and Cosmetics01/25/2023Develop FSVP
Happy Royal North AmericaFood and Cosmetics01/27/2023Develop FSVP
Hong Hae USA, Inc.Food and Cosmetics07/31/2023Develop FSVP
Hong Hae USA, Inc.Food and Cosmetics07/31/2023Evaluation - performance, risk
Hong Hae USA, Inc.Food and Cosmetics07/31/2023Verification activity before import, periodically
JFC International, Inc.Food and Cosmetics11/20/2023No HACCP plan
JFC International, Inc.Food and Cosmetics11/20/2023Monitoring - adequacy
Jaymin Enterprises, Corp.Food and Cosmetics02/21/2023Develop FSVP
Kermit Lynch Wine MerchantFood and Cosmetics09/19/2023Hazard analysis written
Kermit Lynch Wine MerchantFood and Cosmetics09/19/2023Supplier approval - document
Kermit Lynch Wine MerchantFood and Cosmetics09/19/2023Verification activity assurance
Kermit Lynch Wine MerchantFood and Cosmetics09/19/2023Verification activity before import, periodically
Khong Guan CorporationFood and Cosmetics06/06/2023Hazard analysis written
Khong Guan CorporationFood and Cosmetics06/06/2023Verification activity frequency
Living Tree Community FoodsFood and Cosmetics03/17/2023Personnel
Living Tree Community FoodsFood and Cosmetics03/17/2023Sanitation of food-contact surfaces - Frequency
Living Tree Community FoodsFood and Cosmetics03/17/2023Hazard analysis - Identification of hazard
Mangal's MarketsFood and Cosmetics04/27/2023Develop FSVP
Mangal's MarketsFood and Cosmetics04/27/2023Verification activity before import, periodically
Mariposa Baking CompanyFood and Cosmetics02/13/2023Personnel
Mariposa Baking CompanyFood and Cosmetics02/13/2023Raw materials - Allergen identification
New Horizon Enterprises, Ltd.Food and Cosmetics05/17/2023Grounds
New Horizon Enterprises, Ltd.Food and Cosmetics05/17/2023Pest control
Organic Spices, Inc.Food and Cosmetics10/24/2023Personnel
Organic Spices, Inc.Food and Cosmetics10/24/2023Sanitary facilities and controls
Pacific Star Produce, LLCFood and Cosmetics08/15/2023Develop FSVP
Pepcol International FoodsFood and Cosmetics03/28/2023LACF compliance
Pepcol International FoodsFood and Cosmetics03/28/2023Hazard analysis biological, chemical, physical
Pepcol International FoodsFood and Cosmetics03/28/2023Supplier approval - document
Pepcol International FoodsFood and Cosmetics03/28/2023Verification activity frequency
Phong Kee Company, LLCFood and Cosmetics07/13/2023Sanitary operations - Plant maintenance
Phong Kee Company, LLCFood and Cosmetics07/13/2023Cleaning and sanitizing substances - Safe and adequate
Phong Kee Company, LLCFood and Cosmetics07/13/2023Equipment and utensils - Design and maintenance
Phong Kee Company, LLCFood and Cosmetics07/13/2023Manufacturing, processing, packing, holding - Controls
Reliance Indian GroceryFood and Cosmetics03/07/2023Develop FSVP
Reliance Indian GroceryFood and Cosmetics03/07/2023Evaluation - performance, risk
Reliance Indian GroceryFood and Cosmetics03/07/2023Supplier approval - document
Reliance Indian GroceryFood and Cosmetics03/07/2023Supplier verification - establish written procedures
Sai Nakshatra Investment, Inc.Food and Cosmetics07/13/2023Develop FSVP
Shrinath Trading, LLCFood and Cosmetics05/03/2023Develop FSVP
Shrinath Trading, LLCFood and Cosmetics05/03/2023Hazard analysis written
Shrinath Trading, LLCFood and Cosmetics05/03/2023Hazard analysis biological, chemical, physical
Shrinath Trading, LLCFood and Cosmetics05/03/2023Evaluation - performance, risk
Shrinath Trading, LLCFood and Cosmetics05/03/2023Supplier approval - document
Shrinath Trading, LLCFood and Cosmetics05/03/2023Supplier verification - establish written procedures
Shrinath Trading, LLCFood and Cosmetics05/03/2023Verification activity frequency
Shrinath Trading, LLCFood and Cosmetics05/03/2023Verification activity - appropriate
Shrinath Trading, LLCFood and Cosmetics05/03/2023Verification activity before import, periodically
Softap, Inc.Drugs12/11/2023Procedures not in writing, fully followed
Softap, Inc.Drugs12/11/2023Training--operations, GMPs, written procedures
Softap, Inc.Drugs12/11/2023Written distribution procedure
Softap, Inc.Drugs12/11/2023Reserve samples identified, representative, stored
Softap, Inc.Drugs12/11/2023Records reviewed annually
Softap, Inc.Drugs12/11/2023Prepared for each batch, include complete information
Softap, Inc.Drugs12/11/2023Complaint Handling Procedure
TP Lin, Inc.Food and Cosmetics08/07/2023Document review entity's hazard analysis
TP Lin, Inc.Food and Cosmetics08/07/2023Evaluation - performance, risk
TP Lin, Inc.Food and Cosmetics08/07/2023Approved supplier procedures - importer established
TP Lin, Inc.Food and Cosmetics08/07/2023Verification activity assurance
The Healthy Baking Company, LLCFood and Cosmetics07/28/2023Manufacturing, processing, packing, holding - Controls
Trans Pacific Assets Management, Corp.Food and Cosmetics08/21/2023Hazard analysis biological, chemical, physical
Trans Pacific Assets Management, Corp.Food and Cosmetics08/21/2023Document review entity's hazard analysis
Trans Pacific Assets Management, Corp.Food and Cosmetics08/21/2023Evaluation - performance, risk
Trans Pacific Assets Management, Corp.Food and Cosmetics08/21/2023Approved supplier procedures - importer established
Trans Pacific Assets Management, Corp.Food and Cosmetics08/21/2023Verification activity assurance
Trans Pacific Assets Management, Corp.Food and Cosmetics08/21/2023Verification activity before import, periodically
Two Bros Food, Inc.Food and Cosmetics04/17/2023Develop FSVP
U. F. Union International Food, Inc.Food and Cosmetics10/17/2023Personnel
U. S. Import Export CorporationFood and Cosmetics04/27/2023Toxic chemicals - Identified, held, stored
U. S. Import Export CorporationFood and Cosmetics04/27/2023Pest control
U. S. Tov, Inc.Food and Cosmetics06/27/2023Hazard analysis written
U. S. Tov, Inc.Food and Cosmetics06/27/2023Reevaluate - 3 years

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