Huber Soda, LLC (DBA Natrium Products)
Form 483 issued December 6, 2024 · Cortland, New York
- Inspection
- Dec 3 – Dec 6, 2024
- Investigators
- Divek R. Jumani· Tanya R. Syffrard
- Observations
- 4
- Pages
- 4
- FEI number
- 1000120310
In short: On December 6, 2024, FDA issued a Form 483 with 4 observations to Huber Soda, LLC (DBA Natrium Products) in Cortland, New York (FEI 1000120310) after an inspection that ran Dec 3 – Dec 6, 2024. The investigators were Divek R. Jumani and Tanya R. Syffrard. Most observations concern production and materials.
At a glance
Production and materials account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the manufacturing process that may be responsible for causing…
- 02
Your water system is inadequate…
- 03
Materials should be handled and stored in a manner to prevent…
- 04
Failure to prevent unauthorized access or changes to data and failure to have adequate controls to…
This inspection in context
Divek R. Jumani
5 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmHuber Soda, LLC (DBA Natrium Products) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Huber Soda, LLC (DBA Natrium Products)?
FDA listed 4 observations on this Form 483, mostly about production and materials. The opening words of each observation are shown on this page.
Who inspected Huber Soda, LLC (DBA Natrium Products)?
Divek R. Jumani and Tanya R. Syffrard are named on this Form 483, for the inspection of Dec 3 – Dec 6, 2024. Each investigator has a profile showing what they cite most.
When was Huber Soda, LLC (DBA Natrium Products) inspected by FDA?
The inspection ran Dec 3 – Dec 6, 2024, and the Form 483 is dated December 6, 2024.
How do I get the full Form 483 for Huber Soda, LLC (DBA Natrium Products)?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.