San Diego City Wire

There were two companies in a city associated with San Diego County that received FDA citations as a result of two inspections conducted in the county in March, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous month.

The citations in the county include:

• Records of acceptable suppliers have not been established.
• Procedures for finished device acceptance have not been adequately established.
• A device history record has not been adequately maintained.

Both 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
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
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