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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Anderson International Foods, Inc. | Food and Cosmetics | 05/10/2023 | Sanitation preventive controls – Implement |
| Anderson International Foods, Inc. | Food and Cosmetics | 05/10/2023 | Sanitation preventive controls – Appropriate (Adequate) |
| Baonanas | Food and Cosmetics | 09/26/2023 | Pest control |
| Baonanas | Food and Cosmetics | 09/26/2023 | Hazard analysis – Conducted |
| Eastern Fresh Nj, LLC | Food and Cosmetics | 08/31/2023 | Sanitary operations – Plant maintenance |
| Eastern Fresh Nj, LLC | Food and Cosmetics | 08/31/2023 | Sanitation Records |
| Family Food Distributors, Inc. | Food and Cosmetics | 06/02/2023 | Supplier approval – document |
| Family Food Distributors, Inc. | Food and Cosmetics | 06/02/2023 | Reevaluate – 3 years |
| Family Food Distributors, Inc. | Food and Cosmetics | 06/02/2023 | Approved supplier procedures – follow, document use |
| Family Food Distributors, Inc. | Food and Cosmetics | 04/05/2023 | Evaluation – performance, risk |
| Family Food Distributors, Inc. | Food and Cosmetics | 04/05/2023 | Record – translate to English |
| Fast-Pak Trading, Inc. | Food and Cosmetics | 08/15/2023 | Develop FSVP |
| Fast-Pak Trading, Inc. | Food and Cosmetics | 08/15/2023 | Hazard analysis biological, chemical, physical |
| Fast-Pak Trading, Inc. | Food and Cosmetics | 08/15/2023 | Supplier approval – document |
| Fast-Pak Trading, Inc. | Food and Cosmetics | 08/15/2023 | Verification activity assurance |
| Goya Foods, Inc. | Food and Cosmetics | 02/01/2023 | Develop FSVP |
| Goya Foods, Inc. | Food and Cosmetics | 02/01/2023 | LACF compliance |
| Goya Foods, Inc. | Food and Cosmetics | 02/01/2023 | Hazard analysis written |
| Goya Foods, Inc. | Food and Cosmetics | 02/01/2023 | Hazard analysis biological, chemical, physical |
| Goya Foods, Inc. | Food and Cosmetics | 02/01/2023 | Supplier verification – establish written procedures |
| Goya Foods, Inc. | Food and Cosmetics | 02/01/2023 | Verification activity assurance |
| Goya Foods, Inc. | Food and Cosmetics | 02/01/2023 | Verification activity before import, periodically |
| Goya Foods, Inc. | Food and Cosmetics | 02/01/2023 | Record – translate to English |
| Kenover Marketing Corporation | Food and Cosmetics | 11/17/2023 | Revaluate – new information |
| Maurice A. Auerbach, Inc. | Food and Cosmetics | 02/22/2023 | Verification activity frequency |
| Maurice A. Auerbach, Inc. | Food and Cosmetics | 02/22/2023 | Audit – document |
| Maurice A. Auerbach, Inc. | Food and Cosmetics | 02/22/2023 | Sampling, testing |
| Maurice A. Auerbach, Inc. | Food and Cosmetics | 02/22/2023 | Verification activity review, assess |
| Maurice A. Auerbach, Inc. | Food and Cosmetics | 02/22/2023 | Record – translate to English |
| Miami Growers, Inc. | Food and Cosmetics | 11/22/2023 | Grounds |
| Miami Growers, Inc. | Food and Cosmetics | 11/22/2023 | Sanitary operations – Plant maintenance |
| Miami Growers, Inc. | Food and Cosmetics | 11/22/2023 | Pest control |
| Portal 724, LLC | Devices | 09/21/2023 | Lack of Written MDR Procedures |
| Portal 724, LLC | Devices | 09/21/2023 | Report of Death or Serious Injury |
| Portal 724, LLC | Devices | 09/21/2023 | Quality audits – Lack of or inadequate procedures |
| Portal 724, LLC | Devices | 09/21/2023 | Design control – no procedures |
| Portal 724, LLC | Devices | 09/21/2023 | Purchasing controls, Lack of or inadequate procedures |
| Portal 724, LLC | Devices | 09/21/2023 | Lack of or inadequate procedures |
| Portal 724, LLC | Devices | 09/21/2023 | Lack of or inadequate complaint procedures |
| Virak Orthopedics, LLC | Devices | 08/25/2023 | Quality Audit/Reaudit – conducted |
| Virak Orthopedics, LLC | Devices | 08/25/2023 | Evaluation of suppliers, contractors, etc., requirements |
| White Toque, Inc. | Food and Cosmetics | 09/21/2023 | Hazard analysis biological, chemical, physical |
| White Toque, Inc. | Food and Cosmetics | 09/21/2023 | Verification activity review, assess |
