There were 13 companies in cities associated with Bergen 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 43.5% decrease from the number of companies cited in the previous year.
Of the 40 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. The second most common type of company cited in the time period worked in the the Devices sector.
Of the companies cited, 11 should take voluntary actions to correct their managing operations (84.6%). Additionally, one company had to take regulatory and/or administrative actions (7.7%).
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.
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 |
|---|---|---|---|
| ARCA Continental | Food and Cosmetics | 04/28/2023 | Sanitary operations – Plant maintenance |
| ARCA Continental | Food and Cosmetics | 04/28/2023 | Pest control |
| Air Culinaire Worldwide | Food and Cosmetics | 07/13/2023 | Manufacturing, processing, packing, holding – Controls |
| Air Culinaire Worldwide | Food and Cosmetics | 07/13/2023 | Hazard analysis – Conducted |
| Air Culinaire Worldwide | Food and Cosmetics | 07/13/2023 | No HACCP plan |
| Castillo Distributors, Inc. | Food and Cosmetics | 02/14/2023 | Evaluation – performance, risk |
| Castillo Distributors, Inc. | Food and Cosmetics | 02/14/2023 | Supplier verification – establish written procedures |
| Castillo Distributors, Inc. | Food and Cosmetics | 02/14/2023 | Verification activity frequency |
| Castillo Distributors, Inc. | Food and Cosmetics | 02/14/2023 | Verification activity before import, periodically |
| Castillo Distributors, Inc. | Food and Cosmetics | 02/14/2023 | Investigate |
| Chemomouthpiece, LLC | Devices | 09/19/2023 | Management review – Lack of or inadequate procedures |
| Chemomouthpiece, LLC | Devices | 09/19/2023 | Purchasing controls, Lack of or inadequate procedures |
| Chemomouthpiece, LLC | Devices | 09/19/2023 | Lack of or inadequate procedures |
| Chemomouthpiece, LLC | Devices | 09/19/2023 | Lack of or inadequate complaint procedures |
| Esu Farms, LLC | Food and Cosmetics | 01/27/2023 | Develop FSVP |
| Jamol Laboratories, Inc. | Drugs | 01/12/2023 | Buildings of Suitable Size, Construction, Location |
| Jamol Laboratories, Inc. | Drugs | 01/12/2023 | Absence of Written Procedures |
| Jamol Laboratories, Inc. | Drugs | 01/12/2023 | Prepared for each batch, include complete information |
| Jamol Laboratories, Inc. | Drugs | 01/12/2023 | No written record of investigation |
| Julie Trading, LLC | Food and Cosmetics | 04/25/2023 | Develop FSVP |
| La Valle Foods USA | Food and Cosmetics | 12/11/2023 | Hazard analysis written |
| Media Plus, LLC | Devices | 03/10/2023 | Management review dates |
| Media Plus, LLC | Devices | 03/10/2023 | Quality Audits – defined intervals |
| Media Plus, LLC | Devices | 03/10/2023 | Design control – no procedures |
| Media Plus, LLC | Devices | 03/10/2023 | Purchasing controls, Lack of or inadequate procedures |
| Media Plus, LLC | Devices | 03/10/2023 | Lack of or inadequate DHR procedures |
| Sterling Seafood Corporation | Food and Cosmetics | 01/05/2023 | Develop FSVP |
| Suneet Mittal, M.D. | Devices | 07/11/2023 | Investigator non-compliance with agreement/plan/regulations |
| Titan Implants, Inc. | Devices | 03/16/2023 | Design validation- Lack of or inadequate procedures |
| Titan Implants, Inc. | Devices | 03/16/2023 | Environmental control Lack of or inadequate procedures |
| Titan Implants, Inc. | Devices | 03/16/2023 | Maintenance schedule, Lack of or inadequate schedule |
| Titan Implants, Inc. | Devices | 03/16/2023 | Lack of or inadequate process validation |
| Titan Implants, Inc. | Devices | 03/16/2023 | Lack of or inadequate procedures – Acceptance activities |
| Titan Implants, Inc. | Devices | 03/16/2023 | Nonconforming product, Lack of or inadequate procedures |
| Titan Implants, Inc. | Devices | 03/16/2023 | Documentation |
| Titan Implants, Inc. | Devices | 03/16/2023 | DHR – not or inadequately maintained |
| Titan Implants, Inc. | Devices | 03/16/2023 | DHR content |
| Titan Implants, Inc. | Devices | 03/16/2023 | Lack of or inadequate complaint procedures |
| University Reproductive Associates, P.C. | Biologics | 01/19/2023 | Design of procedures to ensure compliance |
| University Reproductive Associates, P.C. | Biologics | 01/19/2023 | Risk factors, clinical evidence |
