South Bergen News

There were two companies in cities associated with Bergen 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 a 100% increase over the number of companies cited in the previous month.

The citations in the county include:

• Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
• You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they were clean and suitable for processing.
• You did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms, allergen cross-contact, contamination of food and deterioration of food.

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
Genzyme Corporation	Drugs	03/18/2024	Procedures for sterile drug products
Rudy's Inflight Catering	Food and Cosmetics	03/26/2024	Raw material control - Inspection
Rudy's Inflight Catering	Food and Cosmetics	03/26/2024	Manufacturing, processing, packing, holding - Controls
Rudy's Inflight Catering	Food and Cosmetics	03/26/2024	Food safety plan
Rudy's Inflight Catering	Food and Cosmetics	03/26/2024	No HACCP plan
Rudy's Inflight Catering	Food and Cosmetics	03/26/2024	Contamination