South Alameda News

There were eight companies in cities associated with Alameda County that received FDA citations as a result of eight inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 27.3% decrease from the number of companies cited in the previous quarter.

Of the 29 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.

All of the companies cited should take voluntary actions to correct their managing operations.

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
Acorn Trading, Inc.	Food and Cosmetics	10/23/2023	Qualifications of individuals
Acorn Trading, Inc.	Food and Cosmetics	10/23/2023	Storage and Distribution
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
JFC International, Inc.	Food and Cosmetics	11/20/2023	No HACCP plan
JFC International, Inc.	Food and Cosmetics	11/20/2023	Monitoring - adequacy
Organic Spices, Inc.	Food and Cosmetics	10/24/2023	Personnel
Organic Spices, Inc.	Food and Cosmetics	10/24/2023	Sanitary facilities and controls
Paramount Export Company	Food and Cosmetics	11/29/2023	Hazard analysis written
Paramount Export Company	Food and Cosmetics	11/29/2023	Evaluation - performance, risk
Paramount Export Company	Food and Cosmetics	11/29/2023	Approved supplier procedures - importer established
Paramount Export Company	Food and Cosmetics	11/29/2023	Supplier verification - establish written procedures
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
U. F. Union International Food, Inc.	Food and Cosmetics	10/17/2023	Personnel