Niagara Leader

There was one company in a city associated with Niagara County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

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

The citations in the county include:

• You did not have a written hazard analysis.
• You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
• You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.

The company cited should take a voluntary action to correct its 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
SAKSCO Gourmet Basket Supplies, Inc.	Food and Cosmetics	05/11/2023	Hazard analysis written
SAKSCO Gourmet Basket Supplies, Inc.	Food and Cosmetics	05/11/2023	Evaluation - performance, risk
SAKSCO Gourmet Basket Supplies, Inc.	Food and Cosmetics	05/11/2023	Supplier approval - document
SAKSCO Gourmet Basket Supplies, Inc.	Food and Cosmetics	05/11/2023	Supplier verification - establish written procedures
SAKSCO Gourmet Basket Supplies, Inc.	Food and Cosmetics	05/11/2023	Verification activity before import, periodically
SAKSCO Gourmet Basket Supplies, Inc.	Food and Cosmetics	05/11/2023	Investigate