There were three companies in cities associated with Bergen County that received FDA citations as a result of three inspections conducted in the county in November 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not.
- Routine calibration of automatic equipment is not performed according to a written program designed to assure proper performance.
- Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
All of the companies cited were involved in the Drugs 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.
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 |
|---|---|---|---|
| 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 |
| 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 |

