Union Carbide Corporation
Form 483 issued October 24, 2024 · Hahnville, Louisiana
- Investigator
- Britny Cargo
- Observations
- 3
- Pages
- 3
- FEI number
- 1000022237
In short: On October 24, 2024, FDA issued a Form 483 with 3 observations to Union Carbide Corporation in Hahnville, Louisiana (FEI 1000022237). The investigator was Britny Cargo. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.188 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production records do not contain complete information relating to the production and…
- 02
Deviations from established procedures…
- 03
Equipment used to manufacture and process Active Pharmaceutical Ingredients should be of appropriate design…
This inspection in context
Britny Cargo
1 document · 2024
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in Louisiana.
The firmUnion Carbide Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Union Carbide Corporation?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Union Carbide Corporation?
Britny Cargo is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Union Carbide Corporation inspected by FDA?
This Form 483 is dated October 24, 2024.
How do I get the full Form 483 for Union Carbide Corporation?
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.