Curia Global, Inc.
Form 483 issued May 9, 2025 · Albany, New York
- Investigators
- Alle Angela C. Welker· Jean Claude Garay
- Observations
- 15
- Pages
- 19
- FEI number
- 1000220178
In short: On May 9, 2025, FDA issued a Form 483 with 15 observations to Curia Global, Inc. in Albany, New York (FEI 1000220178). The investigators were Alle Angela C. Welker and Jean Claude Garay. Most observations concern facilities & equipment and clinical (BIMO); the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and clinical (bimo) account for 9 of 15 observations.
Most cited: 21 CFR 211.68 (4×) · 56.115 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to properly maintain buildings and facilities used in the manufacture of API's…
- 02
There is a failure to demonstrate that your manufacturing process can reproducibly manufacture an excipient meeting…
- 03
There is a failure of your quality unit to ensure that there is stability data to…
- 04
There is a failure to have an equipment of the appropriate design, size , suitability for…
This inspection in context
Alle Angela C. Welker
1 document · 2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New York.
The firmCuria Global, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Curia Global, Inc.?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, clinical (BIMO) and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Curia Global, Inc.?
Alle Angela C. Welker and Jean Claude Garay are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Curia Global, Inc. inspected by FDA?
This Form 483 is dated May 9, 2025.
How do I get the full Form 483 for Curia Global, 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.