There were 18 companies in cities associated with Bergen County that received FDA citations as a result of 19 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 38.5% increase over the number of companies cited in the previous year.
Of the 62 citations issued, the most common citation was ‘The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed’.
Most of the companies cited were involved in the Drugs sector. The second most common type of company cited in the time period worked in the Food and Cosmetics sector.
Of the companies cited, 15 should take voluntary actions to correct their managing operations (83.3%). Additionally, three companies had to take regulatory and/or administrative actions (16.7%).
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 |
|---|---|---|---|
| B and A Trading Corporation | Food and Cosmetics | 02/14/2024 | Verification activity before import, periodically |
| Chefler Foods | Food and Cosmetics | 07/18/2024 | Registration |
| Chefler Foods | Food and Cosmetics | 07/18/2024 | Process filing |
| Cosmetic Essence, Inc. | Drugs | 12/06/2024 | Cleaning / Sanitizing / Maintenance |
| Cosmetic Essence, Inc. | Drugs | 12/06/2024 | Investigations of discrepancies, failures |
| Diamond Chemical Company, Inc. | Drugs | 05/16/2024 | Procedures not in writing, fully followed |
| Diamond Chemical Company, Inc. | Drugs | 05/16/2024 | GMP Training Frequency |
| Diamond Chemical Company, Inc. | Drugs | 05/16/2024 | Identity Testing of Each Component |
| Diamond Chemical Company, Inc. | Drugs | 05/16/2024 | Absence of Written Procedures |
| Diamond Chemical Company, Inc. | Drugs | 05/16/2024 | Testing and release for distribution |
| Diamond Chemical Company, Inc. | Drugs | 05/16/2024 | Lack of written stability program |
| GSource, LLC | Devices | 07/30/2024 | Lack of System for Determining MDR Events |
| GSource, LLC | Devices | 07/30/2024 | Lack of or inadequate complaint procedures |
| Genzyme Corporation | Drugs | 03/18/2024 | Procedures for sterile drug products |
| Genzyme Corporation | Biologics | 06/13/2024 | Environmental Monitoring System |
| Genzyme Corporation | Biologics | 06/13/2024 | Procedures for sterile drug products |
| Genzyme Corporation | Biologics | 06/13/2024 | Investigations of discrepancies, failures |
| JC World Bell Company, Inc. | Drugs | 11/19/2024 | Procedures not in writing, fully followed |
| JC World Bell Company, Inc. | Drugs | 11/19/2024 | Calibration/Inspection/Checking not done |
| JC World Bell Company, Inc. | Drugs | 11/19/2024 | Absence of Written Procedures |
| Jamol Laboratories, Inc. | Drugs | 12/12/2024 | Procedures not in writing, fully followed |
| Jamol Laboratories, Inc. | Drugs | 12/12/2024 | Buildings of Suitable Size, Construction, Location |
| Jamol Laboratories, Inc. | Drugs | 12/12/2024 | Equipment Design, Size and Location |
| Jamol Laboratories, Inc. | Drugs | 12/12/2024 | Absence of Written Procedures |
| Jamol Laboratories, Inc. | Drugs | 12/12/2024 | Scientifically sound laboratory controls |
| Jamol Laboratories, Inc. | Drugs | 12/12/2024 | Investigations of discrepancies, failures |
| Julie Trading, LLC | Food and Cosmetics | 05/15/2024 | Very small importer assurances, supplier |
| June Jacobs Labs, LLC | Drugs | 11/04/2024 | Sampling/testing of labeling/packaging materials |
| June Jacobs Labs, LLC | Drugs | 11/04/2024 | Testing and release for distribution |
| June Jacobs Labs, LLC | Drugs | 11/04/2024 | No written record of investigation |
| Martin E. Gutierrez | Drugs | 11/20/2024 | FD-1572, protocol compliance |
| Martin E. Gutierrez | Drugs | 11/20/2024 | Case history records- inadequate or inadequate |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | Procedures not in writing, fully followed |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | GMP Training Frequency |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | Control / Lab Operations Area |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | Following/documenting laboratory controls |
| Micra Biotechnologies, Inc. | Drugs | 08/02/2024 | Scientifically sound laboratory controls |
| North Hudson IVF Center for Fertility & Gynecology, P.C. | Biologics | 07/02/2024 | Testing, screening, donor eligibility procedures |
| North Hudson IVF Center for Fertility & Gynecology, P.C. | Biologics | 07/02/2024 | Listing and interpretation of CD tests performed |
| North Hudson IVF Center for Fertility & Gynecology, P.C. | Biologics | 07/02/2024 | Risk factors, clinical evidence |
| Phillips Precision, Inc. | Devices | 07/17/2024 | Training – Lack of or inadequate procedures |
| Phillips Precision, Inc. | Devices | 07/17/2024 | Contamination control, Lack of or inadequate procedures |
| Phillips Precision, Inc. | Devices | 07/17/2024 | Maintenance schedule, Lack of or inadequate schedule |
| Phillips Precision, Inc. | Devices | 07/17/2024 | Lack of or inadequate process validation |
| Phillips Precision, Inc. | Devices | 07/17/2024 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| Phillips Precision, Inc. | Devices | 07/17/2024 | Lack of or inadequate procedures – Acceptance activities |
| Phillips Precision, Inc. | Devices | 07/17/2024 | Nonconforming product, Lack of or inadequate procedures |
| Phillips Precision, Inc. | Devices | 07/17/2024 | Lack of or inadequate procedures |
| Provence LP | Food and Cosmetics | 08/06/2024 | Personnel |
| Provence LP | Food and Cosmetics | 08/06/2024 | Plant construction and design |
| Provence LP | Food and Cosmetics | 08/06/2024 | Pest control |
| Provence LP | Food and Cosmetics | 08/06/2024 | Manufacturing, processing, packing, holding – Controls |
| Qualimax, LLC | Drugs | 06/13/2024 | Procedures not in writing, fully followed |
| Qualimax, LLC | Drugs | 06/13/2024 | Scientifically sound laboratory controls |
| 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 |
| Specialty Vision, LLC | Devices | 12/19/2024 | Quality System Procedures |
| Specialty Vision, LLC | Devices | 12/19/2024 | Documentation |
| Specialty Vision, LLC | Devices | 12/19/2024 | Product rework procedures, Lack of or inadequate procedures |



