San Diego City Wire

There were five companies in cities associated with San Diego County that received FDA citations as a result of five inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous quarter.

Of the 21 citations issued, the most common citation was 'You did not conduct and document or obtain documentation of one or more supplier verification activities'.

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
Allermed Laboratories, LLC	Biologics	01/31/2024	Lack of quality control unit
Allermed Laboratories, LLC	Biologics	01/31/2024	Procedures not in writing, fully followed
Allermed Laboratories, LLC	Biologics	01/31/2024	Clothing appropriate for duties performed
Allermed Laboratories, LLC	Biologics	01/31/2024	Buildings of Suitable Size, Construction, Location
Allermed Laboratories, LLC	Biologics	01/31/2024	Environmental Monitoring System
Allermed Laboratories, LLC	Biologics	01/31/2024	Buildings not maintained in good state of repair
Allermed Laboratories, LLC	Biologics	01/31/2024	Equipment Design, Size and Location
Allermed Laboratories, LLC	Biologics	01/31/2024	Procedures for sterile drug products
Allermed Laboratories, LLC	Biologics	01/31/2024	Records reviewed annually
Allermed Laboratories, LLC	Biologics	01/31/2024	When to report
Allermed Laboratories, LLC	Biologics	01/31/2024	Reporting Requirements - 15-day alert
S&S Quality Wholesale, Inc.	Food and Cosmetics	02/02/2024	Develop FSVP
S&S Quality Wholesale, Inc.	Food and Cosmetics	02/02/2024	Verification activity before import, periodically
Sacks Holdings, Inc.	Devices	03/29/2024	Acceptable supplier records, inadequate records
Sacks Holdings, Inc.	Devices	03/29/2024	Lack of or inadequate final acceptance procedures
Sacks Holdings, Inc.	Devices	03/29/2024	DHR - not or inadequately maintained
Sun Grown Organic Distributors, Inc.	Food and Cosmetics	02/29/2024	Food contact surface sanitary inspection and maintenance
Sun Grown Organic Distributors, Inc.	Food and Cosmetics	02/29/2024	Prevent hazards on seed
Trade Rooster, Inc.	Food and Cosmetics	03/25/2024	LACF compliance
Trade Rooster, Inc.	Food and Cosmetics	03/25/2024	Supplier approval - document
Trade Rooster, Inc.	Food and Cosmetics	03/25/2024	Verification activity before import, periodically