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FDA Warns New Jersey Cheese Plant for CGMP & PC Violations

​​​​​​​A New Jersey-based cheese company received an FDA warning letter after investigators found CGMP & PC Violations in the firm's production plant.

The US Food and Drug Administration issued a warning letter to ready-to-eat cheese products manufacturer El Abuelito Cheese Inc. this month after agency investigators uncovered a number of serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP & PC rule) in the company’s Paterson, NJ facility. 

The violations of Hazard Analysis and Risk-Based Preventative Controls (21 CFR Part 117, Subpart C) included failing to conduct a hazard analysis for each type of food the facility manufactured, processed, packed, or stored at the site and not preparing and implementing a written food safety plan for each type of food manufactured at the site. 

During the inspection of the Paterson plant, FDA inspectors also found Listeria grayi and Listeria innocua in two areas of the plant. One of the samples was collected on the edges of a conveyor belt. Additional tests by the FDA found that the conditions of the plant could lead to growth of Listeria monocytogenes in the facility. 

To read the full text of the FDA’s warning letter, click here

Established in 1997, El Abuelito Cheese produces Mexican cheeses, sour cream, and meat products, according to the company’s website

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