How many companies in cities across Bergen County received FDA citations in 2024?

How many companies in cities across Bergen County received FDA citations in 2024?
Jim Jones Deputy Commissioner for Human Foods of FDA — Official Website
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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.

Companies Located Within Bergen County Cities and the Citations They Received in 2024
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


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