Buffalo Ledger

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

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

The citations in the county were 'Procedures for finished device acceptance have not been adequately established' and 'You do not have or have not implemented written verification procedures, product specifications and an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation'.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Harmac Medical Products, Inc.	Devices	10/04/2024	Lack of or inadequate final acceptance procedures
Nyumbani Hakuna Matata, LLC	Food and Cosmetics	11/13/2024	Importer verification