There were nine companies in cities associated with Essex County that received FDA citations as a result of 10 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 10% decrease from the number of companies cited in the previous year.
Of the 29 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.
Of the companies cited, six should take voluntary actions to correct their managing operations (66.7%). Additionally, three companies had to take regulatory and/or administrative actions (33.3%).
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 |
|---|---|---|---|
| AACE Pharmaceuticals, Inc. | Drugs | 11/22/2024 | Approve or reject components, products |
| AACE Pharmaceuticals, Inc. | Drugs | 11/22/2024 | Procedures not in writing, fully followed |
| AACE Pharmaceuticals, Inc. | Drugs | 11/22/2024 | Buildings not maintained in good state of repair |
| AACE Pharmaceuticals, Inc. | Drugs | 11/22/2024 | Cleaning / Sanitizing / Maintenance |
| FABI – SAA, Inc. | Food and Cosmetics | 01/09/2024 | Develop FSVP |
| FABI – SAA, Inc. | Food and Cosmetics | 12/20/2024 | Develop FSVP |
| FABI – SAA, Inc. | Food and Cosmetics | 12/20/2024 | Verification activity – appropriate |
| Fairy Tales Hair Care, Inc. | Drugs | 10/22/2024 | Procedures not in writing, fully followed |
| Hawk Dairy, LLC | Food and Cosmetics | 03/22/2024 | Plant construction and design |
| Hawk Dairy, LLC | Food and Cosmetics | 03/22/2024 | Sanitary operations – Plant sanitation |
| Hawk Dairy, LLC | Food and Cosmetics | 03/22/2024 | Pest control |
| Hawk Dairy, LLC | Food and Cosmetics | 03/22/2024 | Sanitary facilities and controls |
| Hawk Dairy, LLC | Food and Cosmetics | 03/22/2024 | Equipment and utensils – Design and maintenance |
| Hawk Dairy, LLC | Food and Cosmetics | 03/22/2024 | Food safety plan |
| Leading Pharma, LLC | Drugs | 10/21/2024 | Computer control of master formula records |
| Leading Pharma, LLC | Drugs | 10/21/2024 | Absence of Written Procedures |
| Leading Pharma, LLC | Drugs | 10/21/2024 | In-process materials characteristics testing |
| Leading Pharma, LLC | Drugs | 10/21/2024 | Test methods |
| Leading Pharma, LLC | Drugs | 10/21/2024 | Investigations of discrepancies, failures |
| Mega Products | Food and Cosmetics | 08/13/2024 | Importer verification |
| Ruth Special Food Store, LLC | Food and Cosmetics | 01/31/2024 | Develop FSVP |
| Seafish, LLC | Food and Cosmetics | 04/23/2024 | Plant construction and design |
| Seafish, LLC | Food and Cosmetics | 04/23/2024 | HACCP plan implementation |
| Seafish, LLC | Food and Cosmetics | 04/23/2024 | Signed and dated |
| Seafish, LLC | Food and Cosmetics | 04/23/2024 | Sanitation Records |
| Seafish, LLC | Food and Cosmetics | 04/23/2024 | Importer verification |
| Welch, Holme & Clark Company, Inc. | Drugs | 07/10/2024 | Procedures not in writing, fully followed |
| Welch, Holme & Clark Company, Inc. | Drugs | 07/10/2024 | GMP Training Frequency |
| Welch, Holme & Clark Company, Inc. | Drugs | 07/10/2024 | Computer control of master formula records |
