Curia India Private Limited
Form 483 issued February 16, 2024 · Waluj, India
- Inspection
- Feb 12 – Feb 16, 2024
- Investigator
- Youkeun Kim
- Observations
- 1
- Pages
- 1
- FEI number
- 3008580576
In short: On February 16, 2024, FDA issued a Form 483 with 1 observation to Curia India Private Limited in Waluj, Maharashtra (FEI 3008580576) after an inspection that ran Feb 12 – Feb 16, 2024. The investigator was Youkeun Kim. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory methods and procedures…
This inspection in context
Youkeun Kim
13 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmCuria India Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Curia India Private Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Curia India Private Limited?
Youkeun Kim is named on this Form 483, for the inspection of Feb 12 – Feb 16, 2024. Each investigator has a profile showing what they cite most.
When was Curia India Private Limited inspected by FDA?
The inspection ran Feb 12 – Feb 16, 2024, and the Form 483 is dated February 16, 2024.
How do I get the full Form 483 for Curia India Private Limited?
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.