There were 11 companies in cities associated with Passaic County that received FDA citations as a result of 12 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 21.4% decrease from the number of companies cited in the previous year.
Of the 32 citations issued, the most common citations were ‘You did not take a reasonable measure or precaution related to personnel practices’ and ‘You did not develop an FSVP’.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, 10 should take voluntary actions to correct their managing operations (90.9%). Additionally, one company had to take regulatory and/or administrative actions (9.1%).
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| American Eel Depot | Food and Cosmetics | 06/20/2024 | Importer verification |
| Balkanica | Food and Cosmetics | 10/24/2024 | Hazard analysis biological, chemical, physical |
| Balkanica | Food and Cosmetics | 10/24/2024 | Audit – document |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Lack of quality control unit |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Training , Education , Experience overall |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Equipment Design, Size and Location |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Written procedures not established/followed |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Component identity verification |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Absence of Written Procedures |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Testing and release for distribution |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Adequate number of batches on stability |
| Clean Solutions, LLC | Drugs | 05/10/2024 | Review of representative number of batches |
| Euro Foods Group USA NJ, Inc. | Food and Cosmetics | 02/29/2024 | SSOP(S) |
| Euro Foods Group USA NJ, Inc. | Food and Cosmetics | 02/29/2024 | Importer verification |
| Euro Foods Group USA NJ, Inc. | Food and Cosmetics | 11/06/2024 | Develop FSVP |
| European Natural Foods & Trading Company, Inc. | Food and Cosmetics | 08/28/2024 | Develop FSVP |
| Fresh Dough Company | Food and Cosmetics | 09/09/2024 | Personnel |
| Fresh Dough Company | Food and Cosmetics | 09/09/2024 | Sanitation of food-contact surfaces – Frequency |
| Little Kiki, Inc. | Food and Cosmetics | 07/08/2024 | Develop FSVP |
| Little Kiki, Inc. | Food and Cosmetics | 07/08/2024 | Hazard analysis biological, chemical, physical |
| Little Kiki, Inc. | Food and Cosmetics | 07/08/2024 | Document review entity’s hazard analysis |
| Little Kiki, Inc. | Food and Cosmetics | 07/08/2024 | Verification activity review, assess |
| Martinez Imports, LLC | Food and Cosmetics | 08/01/2024 | Personnel |
| Martinez Imports, LLC | Food and Cosmetics | 08/01/2024 | Pest control |
| Moda Food, LLC | Food and Cosmetics | 06/12/2024 | Hazard analysis written |
| Moda Food, LLC | Food and Cosmetics | 06/12/2024 | Evaluation – performance, risk |
| Moda Food, LLC | Food and Cosmetics | 06/12/2024 | Supplier approval – document |
| Moda Food, LLC | Food and Cosmetics | 06/12/2024 | Approved supplier procedures – follow, document use |
| Oaxaca Mexican Quality Products | Food and Cosmetics | 10/23/2024 | Sanitary facilities and controls |
| Oaxaca Mexican Quality Products | Food and Cosmetics | 10/23/2024 | Food safety plan |
| Tortillas Mi Puebilito, LLC | Food and Cosmetics | 07/12/2024 | Personnel |
| Tortillas Mi Puebilito, LLC | Food and Cosmetics | 07/12/2024 | Food safety plan |
