There were two companies in a city associated with Hudson County that received FDA citations as a result of two inspections conducted in the county in November 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous month.
The citations in the county include:
- You did not implement the monitoring procedures listed in your HACCP plan.
- Written MDR procedures have not been implemented.
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
The companies cited were involved in either Food and Cosmetics or Devices sectors.
Both 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 |
|---|---|---|---|
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | Lack of Written MDR Procedures |
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | Management review – defined interval, sufficient frequency |
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | Quality audits – Lack of or inadequate procedures |
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | Training records |
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | Design validation – Risk analysis |
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | Purchasing controls, Lack of or inadequate procedures |
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | Production processes |
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | Documentation |
| George Taub Products & Fusion Company, Inc. | Devices | 11/20/2024 | DMR – not or inadequately maintained |
| Yama Seafood, Inc. | Food and Cosmetics | 11/15/2024 | HACCP plan implementation |



