West Hudson Valley News

There were two companies in a city associated with Ulster County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

• You did not conduct operations under conditions and controls necessary to minimize the potential for allergen cross-contact.
• The quality control unit lacks the responsibility and authority to approve and reject all drug products.
• Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

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
Lagusta's Luscious, LLC	Food and Cosmetics	12/14/2023	Manufacturing, processing, packing, holding - Controls
Ultra Seal Corporation	Drugs	09/20/2023	Approve or reject components, products
Ultra Seal Corporation	Drugs	09/20/2023	Equipment Design, Size and Location
Ultra Seal Corporation	Drugs	09/20/2023	Written procedures not established/followed
Ultra Seal Corporation	Drugs	09/20/2023	Control procedures to monitor and validate performance
Ultra Seal Corporation	Drugs	09/20/2023	Storage under appropriate conditions