There were eight companies in cities associated with Essex County that received FDA citations as a result of nine inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 20% decrease from the number of companies cited in the previous year.
The citations in the county include:
- Your hazard analysis did not identify a hazard that requires a control.
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier’s performance and the risk posed by a food.
- You did not document that you promptly reevaluated a foreign supplier’s performance or the risk posed by a food when you became aware of new information about the foreign supplier’s performance or the risk posed by a food.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).
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 |
|---|---|---|---|
| Bacik Company of NY, Inc. | Food and Cosmetics | 04/25/2023 | Verification activity – appropriate |
| Dara Food, LLC | Food and Cosmetics | 01/20/2023 | Hazard analysis biological, chemical, physical |
| Dara Food, LLC | Food and Cosmetics | 01/20/2023 | Evaluation – performance, risk |
| Dara Food, LLC | Food and Cosmetics | 01/20/2023 | Revaluate – new information |
| Dara Food, LLC | Food and Cosmetics | 01/20/2023 | Supplier verification – establish written procedures |
| Flying Food Group, LLC | Food and Cosmetics | 08/09/2023 | Hazard analysis – Identification of hazard |
| Flying Food Group, LLC | Food and Cosmetics | 08/09/2023 | Hazard analysis |
| Nasto’s Ice Cream Company | Food and Cosmetics | 05/22/2023 | Food safety plan |
| Newark Beth Israel Medical Center – Blood Bank | Biologics | 10/13/2023 | Establish, maintain and follow manufacturing SOPs |
| Newark Beth Israel Medical Center – Blood Bank | Biologics | 10/13/2023 | Concurrent documentation |
| Parker Laboratories, Inc. | Drugs | 06/14/2023 | Reports of Analysis (Components) |
| Parker Laboratories, Inc. | Drugs | 06/14/2023 | Absence of Written Procedures |
| Parker Laboratories, Inc. | Drugs | 06/14/2023 | Lack of written stability program |
| Parker Laboratories, Inc. | Drugs | 06/14/2023 | Items to cover on annual reviews |
| Parker Laboratories, Inc. | Drugs | 06/14/2023 | Actual yield, % of theoretical yield |
| Parker Laboratories, Inc. | Devices | 05/23/2023 | Production and Process Change Procedures, lack of or Inad. |
| Parker Laboratories, Inc. | Devices | 05/23/2023 | Lack of or inadequate process validation |
| Parker Laboratories, Inc. | Devices | 05/23/2023 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| Parker Laboratories, Inc. | Devices | 05/23/2023 | Product rework documentation, DHR {see also 820.184} |
| Spice Import Export, Inc. | Food and Cosmetics | 06/07/2023 | Develop FSVP |
| Trin Jam Distributors, Inc. | Food and Cosmetics | 09/29/2023 | Hazard analysis – Conducted |
| Trin Jam Distributors, Inc. | Food and Cosmetics | 09/29/2023 | Signed and dated |
| Trin Jam Distributors, Inc. | Food and Cosmetics | 09/29/2023 | Calibration – adequacy |
| Trin Jam Distributors, Inc. | Food and Cosmetics | 09/29/2023 | Verification – corrective action |
| Trin Jam Distributors, Inc. | Food and Cosmetics | 09/29/2023 | Records – content |
