# FDA 483 - Curia New York, Inc. - May 18, 2015

Source: https://www.keypedia.com/records/483/curia-new-york-inc/d217f83f-09d7-46a4-a936-ebb673a5958f

> FDA 483 for Curia New York, Inc. on May 18, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curia New York, Inc.
- Inspection Date: 2015-05-18
- Product Type: drugs
- Office Name: Office of Human and Animal Foods Operations - East
- Summary: AMRI Rensselaer Inc. in Rensselaer, NY, an API manufacturer, was cited for five observations during an FDA inspection from May 18-22, 2015. The inspection revealed significant issues related to material storage conditions, deviation investigations, sample labeling, and equipment calibration, indicating a lack of adherence to established procedures and quality control.

## Related Officers

- [Investigator](https://www.keypedia.com/people/frank-wackes/ebbfd9b6-d4e6-4f4d-a071-52e7c46f0b5a)
- [Investigator -Federal Program Manager](https://www.keypedia.com/people/chad-n-thompson/f99444f7-cffb-43d0-b102-315d12115b9e)

Company: https://www.keypedia.com/companies/curia-new-york-inc/af5afa88-d7a2-4f74-a387-edbcf6a6e666

Office: https://www.keypedia.com/offices/office-of-human-and-animal-foods-operations-east/f35344fc-4cf2-4605-b1cf-163d65050588