There were seven companies in cities associated with Union County that received FDA citations as a result of seven inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 16.7% increase over the number of companies cited in the previous year.
Of the 26 citations issued, the most common citation was ‘You did not develop an FSVP’.
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 |
|---|---|---|---|
| Almark Tool & Manufacturing Company, Inc. | Devices | 02/07/2023 | Lack of Written MDR Procedures |
| Almark Tool & Manufacturing Company, Inc. | Devices | 02/07/2023 | Training – Lack of or inadequate procedures |
| Almark Tool & Manufacturing Company, Inc. | Devices | 02/07/2023 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Almark Tool & Manufacturing Company, Inc. | Devices | 02/07/2023 | DMR – not or inadequately maintained |
| Almark Tool & Manufacturing Company, Inc. | Devices | 02/07/2023 | DHR – not or inadequately maintained |
| Almark Tool & Manufacturing Company, Inc. | Devices | 02/07/2023 | Lack of or inadequate complaint procedures |
| Atul J. Enterprises, LLC | Food and Cosmetics | 03/24/2023 | Personnel |
| Atul J. Enterprises, LLC | Food and Cosmetics | 03/24/2023 | Plant construction and design |
| Atul J. Enterprises, LLC | Food and Cosmetics | 03/24/2023 | Cleaning and sanitizing substances – Safe and adequate |
| Atul J. Enterprises, LLC | Food and Cosmetics | 03/24/2023 | Equipment and utensils – Design and maintenance |
| Atul J. Enterprises, LLC | Food and Cosmetics | 03/24/2023 | Food safety plan |
| Indian Foods & Spices, LLC | Food and Cosmetics | 04/17/2023 | Develop FSVP |
| Indian Foods & Spices, LLC | Food and Cosmetics | 04/17/2023 | Hazard analysis biological, chemical, physical |
| Indian Foods & Spices, LLC | Food and Cosmetics | 04/17/2023 | Evaluation – performance, risk |
| Indian Foods & Spices, LLC | Food and Cosmetics | 04/17/2023 | Approved supplier procedures – importer established |
| Indian Foods & Spices, LLC | Food and Cosmetics | 04/17/2023 | Verification activity assurance |
| International Coconut Corporation | Food and Cosmetics | 06/27/2023 | Sanitary facilities and controls |
| International Coconut Corporation | Food and Cosmetics | 06/27/2023 | Hazard analysis – Identification of hazard |
| International Coconut Corporation | Food and Cosmetics | 06/27/2023 | Process preventive controls – Implement |
| International Coconut Corporation | Food and Cosmetics | 06/27/2023 | Sanitation preventive controls – Appropriate (Adequate) |
| International Coconut Corporation | Food and Cosmetics | 06/27/2023 | Supply-chain program – Establish |
| LA Serranita Import and Export, LLC | Food and Cosmetics | 04/19/2023 | Develop FSVP |
| The Sperm and Embryo Bank of New Jersey, Inc. | Biologics | 09/05/2023 | Responsible person to determine, document |
| The Sperm and Embryo Bank of New Jersey, Inc. | Biologics | 09/05/2023 | Specimen collections not timely |
| The Sperm and Embryo Bank of New Jersey, Inc. | Biologics | 09/05/2023 | Reproductive cells or tissues-cell-associated CD |
| Twin City | Food and Cosmetics | 08/02/2023 | Develop FSVP |
