Curia New York, Inc.
Form 483 issued May 22, 2015 · Rensselaer, New York
- Inspection
- May 18 – May 22, 2015
- Investigators
- Chad N. Thompson· Frank Wackes
- Observations
- 5
- Pages
- 2
- FEI number
- 1310298
In short: On May 22, 2015, FDA issued a Form 483 with 5 observations to Curia New York, Inc. in Rensselaer, New York (FEI 1310298) after an inspection that ran May 18 – May 22, 2015. The investigators were Chad N. Thompson and Frank Wackes. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.192 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Samples of Trientine HCL, USP, submitted for analytical testing within the Quality Control Laboratory, were observed…
This inspection in context
Chad N. Thompson
7 documents · 2013–2020
Cites 211.42 (design and construction features) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Curia New York, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and quality system. 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 New York, Inc.?
Chad N. Thompson and Frank Wackes are named on this Form 483, for the inspection of May 18 – May 22, 2015. Each investigator has a profile showing what they cite most.
When was Curia New York, Inc. inspected by FDA?
The inspection ran May 18 – May 22, 2015, and the Form 483 is dated May 22, 2015.
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.