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 |
