There were six companies in cities associated with Bergen County that received FDA citations as a result of six inspections conducted in the county over the fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous quarter.
Of the 19 citations issued, the most common citation was ‘The responsibilities and procedures applicable to the quality control unit are not’.
Most of the companies cited were involved in the Drugs sector.
Of the companies cited, five should take voluntary actions to correct their managing operations (83.3%). Additionally, one company 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Cosmetic Essence, Inc. | Drugs | 12/06/2024 | Cleaning / Sanitizing / Maintenance |
| Cosmetic Essence, Inc. | Drugs | 12/06/2024 | 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 |
| 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 |
| 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 |
