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Wednesday, November 6, 2024

How many companies in cities across Hudson County received FDA citations in 2023?

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

There were 12 companies in cities associated with Hudson County that received FDA citations as a result of 13 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 140% increase over the number of companies cited in the previous year.

Of the 43 citations issued, the most common citations were 'Your hazard analysis did not identify a hazard that requires a control' and 'You did not provide an English translation of an FSVP record that you maintained in a language other than English'.

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

All of the companies cited should take voluntary actions to correct their managing operations.

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.

Companies Located Within Hudson County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Anderson International Foods, Inc.Food and Cosmetics05/10/2023Sanitation preventive controls - Implement
Anderson International Foods, Inc.Food and Cosmetics05/10/2023Sanitation preventive controls - Appropriate (Adequate)
BaonanasFood and Cosmetics09/26/2023Pest control
BaonanasFood and Cosmetics09/26/2023Hazard analysis - Conducted
Eastern Fresh Nj, LLCFood and Cosmetics08/31/2023Sanitary operations - Plant maintenance
Eastern Fresh Nj, LLCFood and Cosmetics08/31/2023Sanitation Records
Family Food Distributors, Inc.Food and Cosmetics06/02/2023Supplier approval - document
Family Food Distributors, Inc.Food and Cosmetics06/02/2023Reevaluate - 3 years
Family Food Distributors, Inc.Food and Cosmetics06/02/2023Approved supplier procedures - follow, document use
Family Food Distributors, Inc.Food and Cosmetics04/05/2023Evaluation - performance, risk
Family Food Distributors, Inc.Food and Cosmetics04/05/2023Record - translate to English
Fast-Pak Trading, Inc.Food and Cosmetics08/15/2023Develop FSVP
Fast-Pak Trading, Inc.Food and Cosmetics08/15/2023Hazard analysis biological, chemical, physical
Fast-Pak Trading, Inc.Food and Cosmetics08/15/2023Supplier approval - document
Fast-Pak Trading, Inc.Food and Cosmetics08/15/2023Verification activity assurance
Goya Foods, Inc.Food and Cosmetics02/01/2023Develop FSVP
Goya Foods, Inc.Food and Cosmetics02/01/2023LACF compliance
Goya Foods, Inc.Food and Cosmetics02/01/2023Hazard analysis written
Goya Foods, Inc.Food and Cosmetics02/01/2023Hazard analysis biological, chemical, physical
Goya Foods, Inc.Food and Cosmetics02/01/2023Supplier verification - establish written procedures
Goya Foods, Inc.Food and Cosmetics02/01/2023Verification activity assurance
Goya Foods, Inc.Food and Cosmetics02/01/2023Verification activity before import, periodically
Goya Foods, Inc.Food and Cosmetics02/01/2023Record - translate to English
Kenover Marketing CorporationFood and Cosmetics11/17/2023Revaluate - new information
Maurice A. Auerbach, Inc.Food and Cosmetics02/22/2023Verification activity frequency
Maurice A. Auerbach, Inc.Food and Cosmetics02/22/2023Audit - document
Maurice A. Auerbach, Inc.Food and Cosmetics02/22/2023Sampling, testing
Maurice A. Auerbach, Inc.Food and Cosmetics02/22/2023Verification activity review, assess
Maurice A. Auerbach, Inc.Food and Cosmetics02/22/2023Record - translate to English
Miami Growers, Inc.Food and Cosmetics11/22/2023Grounds
Miami Growers, Inc.Food and Cosmetics11/22/2023Sanitary operations - Plant maintenance
Miami Growers, Inc.Food and Cosmetics11/22/2023Pest control
Portal 724, LLCDevices09/21/2023Lack of Written MDR Procedures
Portal 724, LLCDevices09/21/2023Report of Death or Serious Injury
Portal 724, LLCDevices09/21/2023Quality audits - Lack of or inadequate procedures
Portal 724, LLCDevices09/21/2023Design control - no procedures
Portal 724, LLCDevices09/21/2023Purchasing controls, Lack of or inadequate procedures
Portal 724, LLCDevices09/21/2023Lack of or inadequate procedures
Portal 724, LLCDevices09/21/2023Lack of or inadequate complaint procedures
Virak Orthopedics, LLCDevices08/25/2023Quality Audit/Reaudit - conducted
Virak Orthopedics, LLCDevices08/25/2023Evaluation of suppliers, contractors, etc., requirements
White Toque, Inc.Food and Cosmetics09/21/2023Hazard analysis biological, chemical, physical
White Toque, Inc.Food and Cosmetics09/21/2023Verification activity review, assess

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