George Taub Products & Fusion Co,, Inc
Form 483 issued November 20, 2024 · Jersey City, New Jersey
- Inspection
- Oct 30 – Nov 20, 2024
- Investigator
- Esteban Beltran
- Observations
- 9
- Pages
- 7
- FEI number
- 2241860
In short: On November 20, 2024, FDA issued a Form 483 with 9 observations to George Taub Products & Fusion Co,, Inc in Jersey City, New Jersey (FEI 2241860) after an inspection that ran Oct 30 – Nov 20, 2024. The investigator was Esteban Beltran. Most observations concern management controls and production & process controls.
At a glance
Observations span 4 systems, led by management controls.
What FDA observed
Preview: the opening words of each observation- 01
A device master record has…
- 02
Production processes were not de veloped to ensure that a device…
- 03
Personnel training is not…
- 04
Corrective and preventive action activities and/or results have…
This inspection in context
Esteban Beltran
9 documents · 2017–2025
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmGeorge Taub Products & Fusion Co,, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at George Taub Products & Fusion Co,, Inc?
FDA listed 9 observations on this Form 483, mostly about management controls, production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected George Taub Products & Fusion Co,, Inc?
Esteban Beltran is named on this Form 483, for the inspection of Oct 30 – Nov 20, 2024. Each investigator has a profile showing what they cite most.
When was George Taub Products & Fusion Co,, Inc inspected by FDA?
The inspection ran Oct 30 – Nov 20, 2024, and the Form 483 is dated November 20, 2024.
How do I get the full Form 483 for George Taub Products & Fusion Co,, Inc?
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