Curia New York, Inc.
Form 483 issued November 1, 2023 · Rensselaer, New York
- Inspection
- Oct 24 – Nov 1, 2023
- Investigators
- Armen H. Youssoufian· Erik W. Koester
- Observations
- 2
- Pages
- 3
- FEI number
- 1310298
In short: On November 1, 2023, FDA issued a Form 483 with 2 observations to Curia New York, Inc. in Rensselaer, New York (FEI 1310298) after an inspection that ran Oct 24 – Nov 1, 2023. The investigators were Armen H. Youssoufian and Erik W. Koester. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The firm’s Quality Unit has failed to review and approve the following complaint investigations within a…
This inspection in context
Armen H. Youssoufian
9 documents · 2023–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmCuria New York, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Curia New York, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Curia New York, Inc.?
Armen H. Youssoufian and Erik W. Koester are named on this Form 483, for the inspection of Oct 24 – Nov 1, 2023. Each investigator has a profile showing what they cite most.
When was Curia New York, Inc. inspected by FDA?
The inspection ran Oct 24 – Nov 1, 2023, and the Form 483 is dated November 1, 2023.
How do I get the full Form 483 for Curia New York, Inc.?
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.