# FDA 483 - Curia New York, Inc. - November 01, 2023

Source: https://www.keypedia.com/records/483/curia-new-york-inc/101aef8f-3aad-4d99-a081-87b755ca86a5

> FDA 483 for Curia New York, Inc. on November 01, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Curia New York, Inc.
- Inspection Date: 2023-11-01
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Curia New York, Inc. in Rensselaer, NY, an API manufacturer, was cited for two significant observations during an FDA inspection. The firm failed to maintain adequate cleanliness in critical areas, including a walk-in cooler storing raw materials and laboratory balance enclosures. Additionally, the Quality Unit did not timely review and approve complaint investigations according to their own procedures.

## Related Officers

- [Armen Youssoufian](https://www.keypedia.com/people/armen-youssoufian/61211f8d-64a8-4d38-af4c-9c71281964c1)
- [Erik Koster](https://www.keypedia.com/people/erik-koster/7fb7eb68-8ee6-4e64-bd7b-281fc0617db8)

Company: https://www.keypedia.com/companies/curia-new-york-inc/bf44876f-aa67-4c38-95e4-21ce3b62feaa

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94