Passaic Today

There were 13 companies in cities associated with Passaic County that received FDA citations as a result of 14 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 30% increase over the number of companies cited in the previous year.

Of the 32 citations issued, the most common citation was 'You did not develop an FSVP'.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, 11 should take voluntary actions to correct their managing operations (84.6%). Additionally, two companies had to take regulatory and/or administrative actions (15.4%).

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
Abuelito Cheese, Inc.	Food and Cosmetics	10/31/2023	Modified requirement: Temperature control - Implement
Agri-Exotic Trading, Inc.	Food and Cosmetics	04/21/2023	Plant construction and design
Agri-Exotic Trading, Inc.	Food and Cosmetics	04/21/2023	Sanitary operations - Plant sanitation
Agri-Exotic Trading, Inc.	Food and Cosmetics	04/21/2023	Equipment and utensils - Design and maintenance
Agri-Exotic Trading, Inc.	Food and Cosmetics	04/21/2023	Hazard analysis - Conducted
Balkanica	Food and Cosmetics	07/31/2023	Hazard analysis biological, chemical, physical
Balkanica	Food and Cosmetics	07/31/2023	Document review entity's hazard analysis
Balkanica	Food and Cosmetics	07/31/2023	Evaluation - performance, risk
European Natural Foods & Trading Company, Inc.	Food and Cosmetics	04/06/2023	Develop FSVP
Guerrero Imports	Food and Cosmetics	12/11/2023	Sanitary operations - Plant maintenance
Guerrero Imports	Food and Cosmetics	12/11/2023	Storage and Distribution
Inopak, Ltd.	Drugs	08/03/2023	Contract drug products--lack of responsibility
Inopak, Ltd.	Drugs	08/03/2023	Procedures not in writing, fully followed
International Trading Pharm Lab, Inc.	Drugs	09/21/2023	Calibration/Inspection/Checking not done
International Trading Pharm Lab, Inc.	Drugs	09/21/2023	Computer control of master formula records
International Trading Pharm Lab, Inc.	Drugs	09/21/2023	Scientifically sound laboratory controls
International Trading Pharm Lab, Inc.	Drugs	09/21/2023	Investigations of discrepancies, failures
International Trading Pharm Lab, Inc.	Drugs	09/21/2023	Suitability of testing methods verified
La Milagrosa 1, LLC	Food and Cosmetics	06/27/2023	Sanitary facilities and controls
La Milagrosa 1, LLC	Food and Cosmetics	06/27/2023	Food safety plan
Little Kiki, Inc.	Food and Cosmetics	06/08/2023	Develop FSVP
Little Kiki, Inc.	Food and Cosmetics	06/08/2023	Hazard analysis written
Oaxaca Mexican Quality Products	Food and Cosmetics	02/24/2023	Develop FSVP
Optimum Trading, LLC	Food and Cosmetics	12/06/2023	Hazard analysis written
Optimum Trading, LLC	Food and Cosmetics	12/06/2023	Evaluation - performance, risk
Optimum Trading, LLC	Food and Cosmetics	12/06/2023	Approved supplier procedures - follow, document use
Optimum Trading, LLC	Food and Cosmetics	02/08/2023	Importer verification
R. R. Importaciones, Inc.	Food and Cosmetics	10/05/2023	Develop FSVP
SOFIE Company	Drugs	08/11/2023	Orderly handling, prevention of mix-ups, prevention of contamination
SOFIE Company	Drugs	08/11/2023	Documentation of Non-Conforming Product Investigation
SOFIE Company	Drugs	08/11/2023	Labeling and product mix-ups
SOFIE Company	Drugs	08/11/2023	Complaint review