# FDA 483 - Curia New York, Inc. - February 05, 2026

Source: https://www.keypedia.com/records/483/curia-new-york-inc/17d2ce3b-7095-4b8e-bec7-377dea46a9c0

> FDA 483 for Curia New York, Inc. on February 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Curia New York, Inc.
- Inspection Date: 2026-02-05
- Product Type: drugs
- Office Name: New York District Office
- Summary: Curia New York, Inc. in Rensselaer, NY, an API manufacturer, received a Form 483 with 10 observations during an inspection from 01/28/2026 to 02/05/2026. The observations primarily highlight significant data integrity issues, including missing signatures on laboratory records, lack of traceability for electronic data, destruction of original QC records, shared login credentials, and mismatched employee signatures. Additionally, the firm was cited for inadequate quality unit oversight, unverified yield calculations, poorly maintained clean rooms, and improper equipment maintenance and documentation.

## Related Documents

- [483 - 2015-05-18](https://www.keypedia.com/records/483/curia-new-york-inc/d217f83f-09d7-46a4-a936-ebb673a5958f)
- [EIR - 2017-11-09](https://www.keypedia.com/records/eir/curia-new-york-inc/f676c87c-9d4d-4ad8-8e96-d97895fc366f)
- [483 - 2026-02-05](https://www.keypedia.com/records/483/curia-new-york-inc/6eb46d2a-cef7-403e-87fb-d8db1a44c387)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Claude Noel Y. Zanetsie](https://www.keypedia.com/people/claude-noel-y-zanetsie/d2341300-2c9d-4d22-bb70-5b442d4e3b70)
- [Jenny Sung](https://www.keypedia.com/people/jenny-sung/f0bfe57e-92b9-4879-9ac3-1e3483b6486a)

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d