Curia New York, Inc.
Form 483 issued January 1, 2004 · Rensselaer, New York
- Inspection
- Jan 28 – Feb 5, 2026
- Investigators
- Claude Noel Y. Zanetsie· Jenny Sung· Saleem A. Akhtar
- Observations
- 10
- Pages
- 17
- FEI number
- 1310298
In short: On January 1, 2004, FDA issued a Form 483 with 10 observations to Curia New York, Inc. in Rensselaer, New York (FEI 1310298) after an inspection that ran Jan 28 – Feb 5, 2026. The investigators were Claude Noel Y. Zanetsie, Jenny Sung and Saleem A. Akhtar. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Facilities & equipment and quality system account for 7 of 10 observations.
Most cited: 21 CFR 211.194 (3×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batches are released without verification if the associated laboratory data was signed off by the analyst…
- 02
Electronic data generated from…
- 03
Original quality control laboratory records were observed in the bin…
- 04
Usernames and passwords of electronic computerized systems…
This inspection in context
Claude Noel Y. Zanetsie
3 documents · 2004–2025
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in New Jersey.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Curia New York, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Curia New York, Inc.?
Claude Noel Y. Zanetsie, Jenny Sung and Saleem A. Akhtar are named on this Form 483, for the inspection of Jan 28 – Feb 5, 2026. Each investigator has a profile showing what they cite most.
When was Curia New York, Inc. inspected by FDA?
The inspection ran Jan 28 – Feb 5, 2026, and the Form 483 is dated January 1, 2004.
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.